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Targeted therapy

Targeted therapies work by attacking specific molecules in cancer cells. Targeted therapy is being studied in early stage and advanced breast cancer.

Halaven® and Afinitor® For Metastatic Triple Negative Breast Cancer

Phase I/IB Trial of Eribulin and Everolimus in Patients With Triple Negative Metastatic Breast Cancer (NCT02120469)

Summary

Researchers are looking for new drugs to treat triple negative (ER-, PR- and HER2-) breast cancer. Eribulin mesylate (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer in patients who have already been treated with other chemotherapy drugs. Everolimus (Afinitor®) is used along with an anti-estrogen drug to treat advanced ER+, HER2- breast cancer. Researchers think it may also be effective in patients who are ER- and HER2-negative.This study is evaluating the safety and best dose of Halaven and Afinitor for treating patients with metastatic triple negative breast cancer.
This is a Phase I trial

CD-839 for Advanced Breast (and other solid) Tumors

A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839, as a Single Agent and in Combination With Chemotherapy in Patients With Advanced Solid Tumors (NCT02071862)

Summary

Researchers are developing new types of targeted cancer therapies. CB-839 is a new type of targeted therapy called a glutaminase inhibitor. Cells use the amino acid glutamine to grow, and CB-839 is designed to block that process. Laboratory studies have shown that CB-839 can slow or stop tumor growth in several different types of tumors. Paclitaxel (Taxol®) is a chemotherapy drug used to treat breast and other types of cancers. This study has two phases. The first phase is designed to determine the best dose of CB-839. This part is open to all breast cancer patients. The second phase will compare the safety and efficacy of CB-839 to CB-839 and Taxol in patients with advanced triple negative breast cancer.
This is a Phase I trial

Radiation and Veliparib After Chemotherapy and Before Surgery

Pre-Operative PARPi and Irradiation (POPI) in Women With an Incomplete Response to Neo-Adjuvant Chemotherapy for Breast Cancer (NCT01618357)

Summary

Giving chemotherapy before surgery (called neoadjuvant therapy) allows doctors to see how the tumor responds to the treatment. It can also shrink the tumor, which may permit a woman to have a lumpectomy instead of a mastectomy. About 20-30 percent of the time, the breast tumor will completely disappear, making it less likely to recur. Veliparib is a type of new cancer treatment called a PARP inhibitor. Laboratory studies have shown that it can make the tumor more likely to respond to radiation and chemotherapy. This study is investigating the safety of combining radiation and Veliparib in women with stage II or III breast cancer whose tumors do not completely disappear after neoadjuvant chemotherapy.
This is a Phase I trial

Perjeta, Herceptin & Abraxane for HER2+ Metastatic Breast Cancer

Phase II Prospective Open Label Single Arm Study of Pertuzumab, Trastuzumab, and Nab-Paclitaxel in Patients With HER-2 Positive Metastatic Breast Cancer (NCT01730833)

Summary

Combining HER2-targeted therapies with chemotherapy may be beneficial when treating HER2+ metastatic breast cancer. Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are both HER2 targeted therapies.The chemotherapy drug nab-paclitaxel (Abraxane®) is routinely used to treat advanced breast cancer. This study is evaluating the effectiveness of combining Perjeta, Herceptin, and Abraxne to treat HER2+ metastatic breast cancer.
This is a Phase II trial

Cabergoline in Metastatic Breast Cancer

A Pilot Phase II Trial of Cabergoline in the Treatment of Metastatic Breast Cancer (NCT01730729)

Summary

Researchers are studying new ways to treat metastatic breast cancer. Prolactin is an endocrine hormone that is produced by the pituitary gland, which is located at the base of the brain. Previous studies have suggested that women who have high levels of the hormone prolactin in their blood may have an increased risk of breast cancer. Cabergoline (Dostinex®) works by lowering prolactin levels in the blood and is used to treat prolactinoma, a benign tumor that can develop in the pituitary gland. This study is looking at whether cabergoline is effective in treating metastatic breast cancer that has a prolactin receptor. Women interested in this trial will have their tumor tested for the prolactin receptor. Only those whose tumors test positive will be able to enroll in the study.
This is a Phase O trial

Saracatinib and Anastrozole for ER-Positive Disease

A Phase I Pharmacokinetic and Randomized Phase II Trial of Neoadjuvant Treatment With Anastrozole Plus AZDO530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer (NCT01216176)

Summary

Researchers are developing new treatments that can target and block enzyme proteins, like Src and Abl, that tell cancer cells to grow. Saracatinib (AZD0530) is a new drug that scientists believe will inhibit both Src and Abl. The goal of this trial is to determine the safety and effectiveness of saracatinib when it is given along with the aromatase inhibitor anastrozole (Arimidex®). In the first part of this study (Phase I), researchers will enroll women with metastatic or locally advanced disease that cannot be removed by surgery. In the second part of this study (Phase II), researchers will enroll women with Stage II or III disease who are planning to have standard surgery.
This is a Phase I-II trial

Triciribine+Paclitaxel in Locally Advanced HER2 Negative Tumors

A Phase I-II Study of Triciribine Phosphate Monohydrate (TCN-PM) Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients With Metastatic and Locally Advanced Breast Cancer (NCT01697293)

Summary

Researchers are studying new drugs and new drug combinations for treating locally advanced breast cancer. Triciribine Phosphate Monohydrate (TCN-PM) is a type of new cancer drug called an AKT inhibitor. AKT is a protein that plays a role in cell growth and cell death. In cancer cells, this protein is not working properly, which helps the tumor grow and spread. The researchers think that giving TCN-PM along with the chemotherapy drug paclitaxel (followed later in time by additional chemotherapy) may be more effective than paclitaxel alone. This study is looking at the affect that giving TCN-PM along with paclitaxel has on HER2-negative locally advanced breast tumors. The first phase of this trial will also enroll patients with stage IV (metastatic) breast cancer.
This is a Phase I-II trial

BYL719 and Taxol For Advanced Breast Cancer

A Phase Ib Open Label Dose Finding Study of BYL719 in Combination With Paclitaxel in Advanced Solid Tumors Followed by Two Expansion Phases in Locally Adv/Met Chemo Naive HER2- Breast Cancer Patients and in Recurrent and Metastatic Head-and-neck Squamous Cell Carcinoma Patients (HNSCC) Pre-treated With Platinum Based Therapy (NCT02051751)

Summary

Researchers are studying the effectiveness of combining chemotherapy drugs with new targeted therapies. BYL719 is a new type of drug called a PI3K inhibitor. It is designed to slow or stop cancer cell growth by blocking the activity of the PI3K protein. Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat breast cancer. This study is designed to determine the safety and best dose of BYL719 when it is given with Taxol to treat advanced breast cancer that has stopped responding to standard treatments.
This is a Phase I trial

Kadcyla or Herceptin After HER2+ Neoadjuvant Therapy & Surgery

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor ...(NCT01772472)

Summary

T-DM1 (Kadcyla®) was recently approved by the FDA for the treatment of HER2-positive metastatic breast cancer. Kadcyla combines the chemotherapy drug DM1 with the HER2-targeted therapy trastuzumab (Herceptin®). This allows the chemotherapy drug to be delivered along with Herceptin directly to the cancer cells. This study is comparing the safety and effectiveness of Kadcyla and Herceptin when they are given after surgery to patients with HER2-positive breast cancer who had some cancer remaining in their breast or axillary lymph nodes following neoadjuvant (pre-operative) therapy with Herceptin and a taxane-based chemotherapy.
This is a Phase III trial

Everolimus & Cisplatin after Neoadjuvant Chemo & Surgery for Triple-Negative Tumors

NEOADJUVANT PHASE II STUDY OF EVEROLIMUS PLUS CISPLATIN IN TRIPLE NEGATIVE BREAST CANCER PATIENTS WITH RESIDUAL DISEASE AFTER STANDARD CHEMOTHERAPY (NCT01931163)

Summary

Researchers are looking at the effectiveness of combining chemotherapy drugs with targeted therapies. Cisplatin (Platinol®) is a chemotherapy drug routinely used to treat breast cancer. Everolimus (Afinitor®) is a targeted therapy used to treat advanced hormone receptor-positive, HER2-negative breast cancer. This study is looking at the safety and effectiveness of using Platinol and Afinitor to treat patients with triple negative tumors who had chemotherapy before surgery (neoadjuvant treatment) that did not fully shrink the tumor.
This is a Phase II trial

Erlotinib and Metformin in Triple Negative Breast Cancer

Phase I Study of Erlotinib and Metformin in Triple Negative Breast Cancer (NCT01650506)

Summary

Researchers are trying to develop new therapies for triple negative (ER-, PR-, and HER2-negative) breast cancer. Metformin, a drug that lowers insulin, is commonly used to treat type 2 diabetes. Studies suggests it might also be an effective breast cancer treatment. Erlotinib (Tarceva®) is a kinase inhibitor that was initially approved for the treatment of nonsmall cell lung cancer. Laboratory studies suggest that metformin and erlotinib have the potential to be an effective combination for treating triple negative breast tumors. The goals of this study are to establish the maximum tolerated dose of the combination of erlotinib and metformin and to determine if the combination is effective in treating patients with triple negative breast cancer.
This is a Phase I trial

BMN-673 With Carboplatin and Paclitaxel in Advanced BRCA+, TNBC and Other Solid Tumors

Phase I Study to Evaluate the Tolerability, Safety and Efficacy of BMN-673 in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumor Malignancies That Have BRCA Mutations or Triple Negative Metastatic Breast Cancer (NCT02358200)

Summary

-Researchers are studying new combination of therapies to treat advanced breast cancer. -Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs that work by causing damage to a cancer cell's DNA. -BMN 673 (talazoparib) is a new type of targeted therapy called PARP inhibitors and have been suggested to be effective in advanced breast cancer with known BRCA mutation. -PARP inhibitors work by preventing PARP protein from repairing damaged DNA in tumor cells. -The goal of this study is to determine the safety, efficacy and best dose of giving BMN 673 and carboplatin in individuals with advanced disease that is either associated with known BRCA mutation or triple-negative status. -Researchers will also determine the effectiveness of adding paclitaxel to the combination for treating individuals with any solid tumors.
This is a Phase I trial

BMS-906024 for Advanced Triple Negative Disease

Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Advanced Solid Tumors (NCT01292655)

Summary

Scientists are trying to develop drugs that work by targeting specific pathways that fuel a tumor's growth. BMS-906024 is a new experimental drug that works by inhibiting the Notch signaling pathway, which plays a role in tumor cell growth and survival. The purpose of this trial is to determine the safety, effectiveness, and best dose of BMS-906024 when it is given to women with triple-negative advanced or metastatic breast cancer who no longer respond to standard therapies.
This is a Phase I trial

The Immunotherapy Opdivo & Abraxane for Recurrent HER2-Negative Metastatic Breast Cancer

A Phase 1, Open-Label, Multicenter, Safety Study of Nivolumab (BMS-936558) in Combination With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer (NCT02309177)

Summary

Researchers are trying to find more effective treatments for metastatic breast cancer. nab-Paclitaxel (Abraxane®) is a chemotherapy drug approved in the treatment of breast cancer that has spread after treatment with combination chemotherapy or that has come back within 6 months after chemotherapy treatment post-surgery. Nivolumab (Opdivo®) is an immunotherapy approved in the treatment of certain types of metastatic melanoma and non-small cell lung cancer. Nivolumab (Opdivo®) blocks a protein called PD-1 (programmed cell death 1). Blocking PD-1 prevents a known pathway found in certain tumors and may allow the body’s own immune cells to attack tumors. This study is primarily evaluating the safety of combining Opdivo with two different regimens of Abraxane in patients with HER2-negative, recurrent metastatic breast cancer. Anti-tumor activity of Opdivo in combination with these two Abraxane regimens will be preliminarily assessed. (This study also is enrolling patients with pancreatic and non-small cell lung cancer).
This is a Phase I trial

Cabozantinib and Falsodex for Hormone-Sensitive, HER2- Bone Metastases

A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone (NCT01441947)

Summary

Researchers are looking for drugs that will be effective in patients that have breast cancer that has spread (metastasized) to the bone. Cabozantinib (Cometriq®) is an experimental targeted therapy that works by inhibiting several different proteins that are believed to help tumors grow, spread, and form new blood vessels. One of these targets is the MET pathway, which aids tumor growth and is also active in bone cells, which is why researchers believe it may be effective in slowing or stopping bone metastases. Fulvestrant (Falsodex®) is commonly used to treat HR-positive, metastatic breast cancer in postmenopausal women who has stopped responding to other hormonal therapy. The goal of this trial is to determine the effectiveness of cabozantinib when given with fulvestrant for individuals with HR-positive, HER2-negative breast cancer that has spread to the bone in postmenopausal women.
This is a Phase II trial

Ruxolitinib and Xeloda in Advanced HER2-Negative Breast Cancer

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer (NCT02120417)

Summary

Ruxolitinib is a new type of targeted therapy that works by blocking the Janus tyrosine Kinase (JAK) signaling pathway. Laboratory studies suggest that cancer cells use this pathway to help them grow and divide. Scientists think that blocking the pathway could be an effective way to treat cancer. Capecitabine (Xeloda®) is an oral chemotherapy drug used to treat metastatic breast cancer. This trial is comparing the safety and effectiveness of using Xeloda and ruxolitinib to using Xeloda alone to treat women with advanced HER2-negative breast cancer.
This is a Phase II trial

BMN 673 Before Surgery for BRCA+ Patients with HER2-Negative Tumors

A Pilot Study of BMN673 as a Neoadjuvant Study in Patients With a Diagnosis of Invasive Breast Cancer and a Deleterious BRCA Mutation (NCT02282345)

Summary

Like normal cells, cancer cells replicate their DNA when they divide. The BRCA and PARP proteins help repair DNA that becomes damaged during cell division. In women with a BRCA mutation, cancer cells are unable to use the BRCA protein to repair damaged DNA and use the PARP protein instead. BMN 673 is a PARP inhibitor, a new type of cancer drug that kills cancer cells by blocking the PARP protein from fixing the damaged DNA. Giving therapy before surgery--called neoadjuvant treatment--allows researchers to study the effect that a cancer therapy has on the cancer cells. This study is evaluating the effect of BMN 673 when it is given before surgery to patients who have an inherited BRCA mutation and have tumors that are HER2-negative. To be eligible, a patient must have a breast tumor that is at least 1 cm in size.
This is a Phase II trial

Kadcyla, Tykerb & Abraxane vs. Herceptin, Tykerb & Taxol Before Surgery for HER2+ Tumors

Randomized Open Label Phase II Trial Of Neoadjuvant Trastuzumab Emtansine (Te) In Combination With Lapatinib (L) Follow by Abraxane (A) Compared With Trastuzumab Plus Lapatinib Follow by Paclitaxel In Her 2 Neu Over-Expressed Breast Cancer Patients (TEAL Trial) (NCT02073487)

Summary

Researchers are trying to identify the most effective drug combination for treating HER2+ breast cancer. T-DM1 (Kadcyla®) combines the chemotherapy drug DM1 with trastuzumab (Herceptin®), a drug used to treat HER2-positive tumors. This allows the chemotherapy drug to be delivered directly to the cancer cells. Lapatinib (Tykerb®) is a targeted therapy used to treat HER2+ breast cancer. Nab-paclitaxel (Abraxane®) is a chemotherapy drug used to treat advanced breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug used to treat breast cancer. Giving chemotherapy before surgery allows researchers to study the effect that a treatment has on the breast tumor. This study is comparing the efficacy of Kadcyla, Tykerb and Abraxane to Herceptin, Tykerb and Taxol when it is given before surgery to patients with HER2+ breast cancer.
This is a Phase II trial

CDK-Inhibitor for Previously Treated Metastatic Disease

Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer (NCT01037790)

Summary

A new target for treating metastatic breast cancer may be cyclin-dependent kinase (CDK), a family of enzymes involved in cell growth. As the name implies, CDK enzymes are only active in the presence of proteins referred to as cyclins. PD 0332991 (Palbociclib) is a new biological therapy that blocks two different cyclin-dependent kinase enzymes. This, in turn, may slow or stop a cancer's growth. The goal of this trial is to determine the side effects of Palbociclib and how well it works in treating patients with tumors that are no longer responding to standard treatment.
This is a Phase II trial

Neratinib & Xeloda or Tykerb & Xeloda for HER2+ Metastases

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (NCT01808573)

Summary

Researchers are studying new drugs and new drug combinations that may be effective in patients with HER2+ metastatic breast cancer. Neratinib is a new drug being studied in patients with HER2+ tumors. By attaching itself to the cancer cells, it keep the HER2 protein from stimulating tumor growth. Lapatinib (Tykerb®) is a targeted therapy used to treat HER2+ advanced breast cancer. Capecitabine (Xeloda®) is a chemotherapy drug used to treat metastatic breast cancer that has not improved after treatment with certain other anticancer drugs. This trial is comparing the combination of neratinib and Xeloda to the combination of Tykerb and Xeloda in patients in HER2+ metastatic breast cancer who already have received two or more HER2 regimens in the metastatic setting.
This is a Phase III trial

SAR566658 for Previously Treated Advanced Disease

Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Adult Patients With DS6-positive and Refractory Solid Tumors (NCT01156870)

Summary

The experimental targeted therapy SAR566658 is a monoclonal antibody attached to a drug that specifically targets and kills tumor cells. This is the first trial to test SAR566658 in humans. The goal of this trial is to determine the safety, effectiveness, and maximum tolerable dose of SAR566658 in individuals with advanced disease who are no longer candidates for standard therapy or for whom there is no standard therapy available.
This is a Phase I trial

Chemotherapy and a PARP-inhibitor for BRCA1/2+, HER2- Advanced Breast Cancer

A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without the Poly ADP-ribose Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic or Locally Advanced Unresectable Breast Cancer Gene (BRCA)-Associated Breast Cancer (NCT02163694)

Summary

Researchers are studying new types of breast cancer drugs and drug combinations. Veliparib is a new type of cancer therapy called a PARP inhibitor. By blocking the PARP enzyme, veliparib keeps cancer cells from repairing DNA damage. Studies suggest that combining veliparib with chemotherapy drugs that damage DNA may make the cancer cells more responsive to the chemotherapy treatment. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs used to treat advanced breast cancer. This study is comparing the effectiveness of veliparib, paraplatin, and Taxol with paraplatin and Taxol alone in treating patients with a BRCA1 or BRCA2 mutation who have advanced HER2-negative breast cancer.
This is a Phase III trial

Entinostat and Lapatinib for HER2-Positive Advanced Disease

Entinostat and Lapatinib Ditosylate in Patients With Locally Recurrent or Distant Relapsed Metastatic Breast Cancer Previously Treated With Trastuzumab (NCT01434303)

Summary

Researchers are looking for new ways to treat HER2+ tumors that do not respond or have stopped responding to the HER2-targeted therapy trastuzumab (Herceptin®). Entinostat is an investigational cancer drug that works by blocking protein enzymes called histone deacetylases (HDAC), which help cells divide. Lapatinib (Tykerb®) is a HER2-targeted therapy approved for the treatment of advanced breast cancer. Researchers are trying to determine the best dose and effectiveness of entinostat when it is given with Tykerb®. To be eligible, participants must have locally recurrent or metastatic HER2-positive disease, and have already been treated with Herceptin. NOTE: INDIVIDUALS WITH INFLAMMATORY BREAST CANCER (IBC) CAN PARTICIPATE IN ONLY THE PHASE I PORTION OF THE STUDY.
This is a Phase I-II trial

Xtandi and Herceptin for HER2+, ER- Advanced Breast Cancer

A Phase 2, Multicenter, Open-label Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Subjects With HER2+ AR+ Metastatic or Locally Advanced Breast Cancer (NCT02091960)

Summary

Studies suggest targeting the androgen receptor (AR) could block breast cancer cell growth. Enzalutamide (Xtandi®) is a drug that blocks the androgen receptor. It is currently used to treat prostate cancer. Trastuzumab (Herceptin®) is used to treat HER2-positive tumors. The purpose of this study is to evaluate the safety and effectiveness of using Xtandi along with Herceptin to treat women with HER2-positive, ER-negative metastatic or locally advanced breast cancer. To be eligible, patient must not have had pertuzumab (Perjeta®) included in their most recent therapy. They must also have their tumor test positive for the androgen receptor (AR+).
This is a Phase II trial

MM-398 for Triple Negative Breast Cancer

A Pilot Study in Patients Treated With MM-398 to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages (NCT01770353)

Summary

Researchers are studying new drugs for treating metastatic triple negative breast cancer. MM-398, a new type of targeted therapy, uses a fat molecule (like a bubble) to deliver the chemotherapy drug irinotecan (Camptosar®) to cancer cells. Because the irinotecan is delivered directly to the cancer cell, it can be given at a higher dose. Ferumoxytol (Feraheme) is used during an MRI to improve imaging. It is being used in this study to measure a type of white blood cell called tumor associated macrophages. The goal of this study is to learn more about how MM-398 travels in the body and whether using ferumoxytol is effective in tracking MM-398.
This is a Phase I trial

Targeted Treatment (Herceptin and Perjeta) for Metastatic Breast Cancer

My Pathway: An Open Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib, and Vismodegib in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents (NCT02091141)

Summary

Researchers are trying to identify more effective ways to treat metastatic cancer. This trial is studying four different types of targeted therapies that may be effective in a number of cancers. The breast cancer patients who enroll in this trial will receive trastuzumab (Herceptin®) and pertuzumab (Perjeta®), two targeted therapies used to treat HER2+ breast cancer. To be eligible for this study, a breast cancer patient must have a HER2+ tumor and already have received a first-line standard treatment for metastatic breast cancer.
This is a Phase II trial

EC1456 For Triple Negative Breast Cancer

A PHASE 1 STUDY OF FOLIC ACID-TUBULYSIN CONJUGATE EC1456 IN PATIENTS WITH ADVANCED SOLID TUMORS (NCT01999738)

Summary

EC1456 is a new type of injectable drug that consists of folate (vitamin B9) linked to a chemotherapy drug called tubulysin B hydrazide (TubBH). The folate receptor is highly expressed in triple negative breast cancer. This suggests that EC1456 might be effective in triple negative breast cancer because the folate would deliver the chemotherapy drug to the cancer cell. This study is evaluating the effect of EC1456 in patients with triple negative breast cancer. This study is also enrolling patients with other types of advanced solid tumors.
This is a Phase I trial

Treating Advanced Breast Cancers With a PIK3CA Mutation

A Phase Ib, Open-label Study of Oral BGJ398 in Combination With Oral BYL719 in Adult Patients With Select Advanced Solid Tumors (NCT01928459)

Summary

BYL719 is a new drug that may get cancer cells to die by blocking a protein called PI3KA. BGJ398 is a new drug that may get cancer cells to die by blocking a protein called FGFR. Both proteins play a role in cancer cell growth. Tumors that have a mutation in a gene called PIK3CA may be less likely to respond to some cancer treatments. This study is investigating the safety of combining BYL719 and BGJ398 in breast cancer patients whose tumors have a PIK3CA mutation. To be eligible, patients must have advanced or metastatic breast cancer for which there is no standard treatment. Patients must also have a tumor that has a PIK3CA mutation and alterations FGFR 1-3. Tumors will be tested for these mutations by the researchers. Patients with other types of solid cancers will also be enrolled in this study.
This is a Phase I trial

Chemotherapy and a Targeted Therapy Before Surgery for Stage III Breast Cancer

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting (NCT02436993)

Summary

Stage II and III tumors are typically treated with chemotherapy before surgery. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs routinely used to treat breast cancer. Bevacizumab (Avastin®) is a targeted therapy that keeps tumors from growing the blood vessels they need to survive. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2-positive breast cancer. In this study patients with HER2-negative tumors will receive chemotherapy and Avastin and patients with HER2-positive tumors will receive chemotherapy along with Herceptin and Perjeta. Researchers will evaluate the safety and efficacy of the two treatment protocols. They will also investigate whether magnetic resonance imaging (MRI) is a good tool for monitoring and predicting how the tumor will respond to the treatment.
This is a Phase II trial

Veliparib & Doxil for Triple Negative Metastatic Breast Cancer

PHASE I STUDY OF ABT-888, PARP INHIBITOR, AND PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) IN RECURRENT GYNECOLOGIC CANCER AND BREAST CANCER (NCT01145430)

Summary

Researchers are developing new treatments for triple negative breast cancers. Veliparib is a poly(ADP-ribose) polymerase (PARP) inhibitor. It blocks an enzyme that plays an important role in cell growth, which can cause cancer cells to die. Studies suggest velaprib can slow or stop the growth of triple negative breast cancer cells. Liposomal doxorubicin hydrochloride (Doxil®) is a chemotherapy drug used to treat breast and other types of cancers. Giving veliparib with Doxil may be more effective than giving veliparib alone. This trial is studying the side effects and the best dose of veliparib when it is given with Doxil to patients with triple negative metastatic breast cancer. (This study is also enrolling women with ovarian, fallopian and peritoneal cancers.)
This is a Phase I trial

LY2835219 and Hormone Therapy for Metastatic Breast Cancer

A Phase 1b Study of LY2835219 in Combination With Endocrine Therapies for Patients With Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (NCT02057133)

Summary

Researchers have developed a new type of targeted therapy called a CDK 4/6 inhibitor. LY2835219 is one of the CDK 4/6 inhibitors now being studied. Laboratory studies suggest that LY2835219 may be an effective treatment for hormone-sensitive metastatic breast cancer. This study is evaluating the safety of using LY2835219 along with standard hormone therapy—Letrozole (Femara®), Anastrozole (Arimidex®), Tamoxifen, Exemestane (Aromasin®), or Exemestane (Aromasin®) and Everolimus (Afinitor®)—to treat women with hormone sensitive, HER2-negative metastatic breast cancer.
This is a Phase I trial

Veliparib For Advanced Disease With Liver or Kidney Problems

Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction (NCT01366144)

Summary

Chemotherapy drugs like paclitaxel (Taxol®) and carboplatin (Paraplatin®) work by causing damage to a cancer cell's DNA. PARP (poly(ADP-ribose) polymerase) inhibitors are a new type of cancer drug. They can make it more difficult for the cancer cell to repair this DNA damage, which may make chemotherapy more effective. The purpose of this trial is to determine the safety and best dose of veliparib in combination with Taxol® and Paraplatin® in patients with advanced disease who also have liver or kidney problems. To be eligible, patients must have liver OR kidney problems. Patients who have both liver and kidney problems are not eligible.
This is a Phase I trial

ARN-810 in Postmenopausal Women With Advanced Breast Cancer

An Open-Label, Phase I Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer (NCT01823835)

Summary

Over time, hormone-sensitive tumors can stop responding to hormone therapies. ARN-810 is a new type of anti-estrogen drug called a selective estrogen receptor degrader. It is designed to block and destroy the hormone receptors that drive tumor growth. Laboratory studies suggest it may be effective in women who have stopped responding to other hormonal therapies. This study is looking at the safety and the most effective dose of ARN-810 for treating postmenopausal women with locally advanced or metastatic hormone-sensitive, HER2-negative breast cancer who have already tried previous hormone therapies.
This is a Phase I trial

BMS-906024 & Chemo For Advanced Triple Negative Breast Cancer

A Phase Ib Ascending Multi-arm, Dose Escalation Study of BMS-906024 Combined With Several Chemotherapy Regimens in Subjects With Advanced or Metastatic Tumors (NCT01653470)

Summary

Researchers are developing new targeted therapies for breast and other solid tumors. BMS-906024 is a new drug that works by inhibiting a pathway, called Notch signaling, that plays a role in tumor cell growth and survival. The purpose of this study is to identify a safe and tolerable dose of BMS-906024 to give along with chemotherapy to treat advanced or metastatic breast cancer. (Patients with other types of solid tumors will also be enrolled in this trial.)
This is a Phase I trial

Olaparib After Chemo for BRCA+ Triple Negative Stage I-III Breast Cancer

A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With ... (NCT02032823)

Summary

Olaparib (Lynparaza) is a new type of drug called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. In tumor cells in women with a BRCA mutation, blocking this enzyme can lead to cell death. In Dec. 2014, Lynparza was approved for treating advanced ovarian cancer in women with a BRCA mutation. Prior studies suggest breast cancer that develops in patients with a BRCA mutation will also respond to Lynparza. This study is comparing the safety and effectiveness of Lynparza to a placebo in women with a BRCA mutation who have had surgery and neoadjuvant or adjuvant chemotherapy to treat early-stage triple-negative breast cancer.
This is a Phase III trial

Olaparib for Treating Metastatic Breast Cancer in Patients with a BRCA1/2 Mutation

A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (NCT02000622)

Summary

Researchers are developing new types of cancer drugs. Olaparib is a new type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the PARP protein from repairing damaged DNA in cancer cells. Previous studies have suggested these drugs may be effective in cancer patients with a BRCA mutation. This study is comparing the safety and effectiveness of olaparib with a typical chemotherapy drug (capecitabine, vinorelbine or eribulin) in patients with metastatic breast cancer who have a BRCA1 or BRCA2 mutation. To be eligible, patients with hormone-sensitive tumors must have already tried at least one endocrine therapy.
This is a Phase III trial

HER2 Therapies with Hormone Therapy or Chemotherapy for Advanced Breast Cancer

1303GCC: Phase II Study of Trastuzumab and Pertuzumab Alone and in Combination With Hormonal Therapy or Chemotherapy With Eribulin in Women Aged 60 and Over With HER2/Neu Overexpressed Locally Advanced and/or Metastatic Breast Carcinoma (NCT02000596)

Summary

Researchers are studying new treatment combinations for advanced HER2+ breast cancer. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2 targeted therapies used to treat HER2+ breast cancer. Anastrozole (Arimidex®) and fulvestrant (Faslodex®) are two of the hormone therapies used to treat advanced breast cancer. Eribulin (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer. Patients who enroll in this study will initially receive Herceptin and Perjeta. If their tumors progress on this treatment, they will receive either Arimidex and Faslodex or Halaven in addition to Herceptin and Perjeta. This study is open to postmenopausal women with locally advanced or metastatic breast cancer.
This is a Phase II trial

Capecitabine + BKM120 in Triple Negatvie Breast Cancer With Brain Metastases

Phase II Multicenter Single-arm Study of BKM120 Plus Capecitabine for Triple Negative Breast Cancer (TNBC) Patients With Brain Metastases (NCT02000882)

Summary

BKM120 is an investigational targeted therapy that works by blocking PI3K, a group of proteins that help cancer cells to grow. Capecitabine (Xeloda®) is a chemotherapy drug used to treat triple negative (ER-, PR-, HER2-) breast cancer. Early studies suggest that combining Xeloda with BKM120 may be an effective way to treat triple-negative breast cancer. These studies have also suggested that this treatment may be able to cross the blood-brain barrier, to kill cancer cells. This study is evaluating the safety and effectiveness of BKM120 and Xeloda in patients with triple-negative breast cancer that has spread to the brain.
This is a Phase II trial

Veliparib, Carboplatin & Chemo Before Surgery in Stage II-III Triple Negative Tumors

A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC) (NCT02032277)

Summary

Researchers are trying to develop the best treatments for triple negative breast cancer. Veliparib (ABT-88) blocks PARP, an enzyme that plays an important role in controlling cancer cell growth. Studies suggest it is effective in triple negative breast cancer. Carboplatin (Paraplatin®) is a chemotherapy drug that studies suggest is effective for triple negative breast cancer. TAC (Taxotere®, Adriamycin®/doxorubicin and cyclophosphamide®) is a chemotherapy regimen routinely used to treat breast cancer. Giving chemotherapy before surgery, called neoadjuvant therapy, allows researchers to study the effect that a drug combination has on breast cancer cells. This study is comparing the safety and effectiveness of three different treatment combinations–veliparib, Paraplatin and TAC; Paraplatin and TAC; and TAC—when they are given before surgery to patients with stage II or stage III triple negative breast cancer.
This is a Phase III trial

Keytruda® with Hypofractionated Radiotherapy for Metastatic Breast Cancer

RADVAX: A Stratified Phase I Trial of Pembrolizumab With Hypofractionated Radiotherapy in Patients With Advanced and Metastatic Cancers (NCT02303990)

Summary

The immunotherapy pembrolizumab (Keytruda®) targets programmed cell death 1 (PD-1), a receptor that keeps the immune system from attacking cancer cells. It is approved for treating metastatic melanoma and is being studied in metastatic breast and other cancers. Hypofractionated radiation delivers larger doses of radiation in less amount of time than standard radiation therapy. This trial is investigating the effectiveness of using hypofractionated radiotherapy in combination with Keytruda for treating metastatic breast (and other advanced) cancers that have progressed on at least one prior therapy.
This is a Phase I trial

Faslodex Combined with LEE011 and BYL719 or BKM120 in Advanced ER+/HER2- Breast Cancer

A Phase Ib/II Study of LEE011 in Combination With Fulvestrant and BYL719 or BKM120 in the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Locally Recurrent or Advanced Metastatic Breast Cancer (NCT02088684)

Summary

Researchers are studying new drugs that may be effective in treating locally advanced or metastatic ER-positive, HER2-negative breast cancer. Fulvestrant (Faslodex®) is used to treat advanced hormone-sensitive breast cancer in postmenopausal women. LEE011, BYL719 and BKM120 are targeted therapies that inhibit enzymes that help cancer cells to grow. LEE011 inhibits CDK4 and CDK 6 enzymes. BYL719 and BKM120 inhibit PI3 kinase enzymes. This study is comparing the effect of LEE011 and Faslodex; LEE011, BMK120 and Faslodex; and LEE011, BKM120 and Faslodex in women with locally advanced or metastatic ER+, HER2- breast cancer.
This is a Phase I-II trial

MEDI4736 and Tremelimumab for Advanced Triple-Negative Breast Cancer

A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors (NCT02261220)

Summary

Researchers are developing new drugs that are designed to get the immune system to recognize and attack specific targets on cancer cells. MEDI4736 is a new type of drug called a PD-1 inhibitor. It blocks a signaling pathway that some tumors use to avoid being attacked by the immune system. Tremelimumab is a new type of drug that activates the immune system by blocking a protein called CTLA-4. This study is evaluating the safety, efficacy and and best dose of MEDI4726 when it is given in combination with tremelimumab for treating advanced triple negative breast cancer and other types of solid tumors.
This is a Phase I trial

Sprycel® After Adjuvant Therapy in Women Treated for Early Stage, ER- Breast Cancer

Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer (NCT01471106)

Summary

Dasatinib (Sprycel®) is a targeted therapy that can decrease the activity of one or more proteins that help cancer cells grow. Sprycel is approved for the treatment of leukemia. Studies suggest it may also be effective for treating breast cancer. Fine needle aspiration is a procedure that allows researchers to study breast cells. Ki-67 is a protein in cells that increases as they prepare to divide into new cells. This study is using fine needle aspiration to study the effect that Sprycel has on Ki-67 in breast cells removed from the unaffected breast of women who have been treated for early-stage ER-negative breast cancer. To be eligible, participants must have completed adjuvant therapy.
This is a Phase II trial

BYL719 & Femara for Hormone-Sensitive Metastatic Breast Cancer

A Phase Ib Trial of BYL719 (an α-Specific PI3K Inhibitor) in Combination With Endocrine Therapy in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer (NCT01791478)

Summary

Researchers are studying new drugs and new drug combinations that may be effective in patients with metastatic breast cancer. BYL719 is a new targeted therapy that works by blocking a protein called PI3K that plays a role in tumor growth. Letrozole (Femara®) is a hormone therapy that is used to treat early-stage and metastatic breast cancer. BYL719 combined with Femara may be more effective than using Femara alone. This trial is studying the side effects and best dose of BYL719 when it is given with Femara to patients with hormone-sensitive metastatic breast cancer.
This is a Phase I trial

Ipatasertib and Taxol® For Advanced Triple-Negative Breast Cancer

A RANDOMIZED, PHASE II, MULTI-CENTER, PLACEBO-CONTROLLED STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR OF AKT, IN COMBINATION WITH PACLITAXEL AS FRONT-LINE TREATMENT FOR PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER (NCT02162719)

Summary

Researchers are studying new drug treatments for triple-negative metastatic breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug used to treat metastatic breast cancer. Ipatasertib (GDC-0068) is a new type of cancer drug called an Akt inhibitor. It works by blocking the Akt protein, which helps tumors grow. Studies suggest ipatasertib may be effective in patients with triple negative tumors. This study is comparing the safety and effectiveness of Taxol and ipatasertib to Taxol and a placebo in patients with locally advanced or metastatic triple-negative breast cancer.
This is a Phase II trial

Study of Cometriq to Treat Brain Metastases

A Phase II Study of Cabozantinib Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases (NCT02260531)

Summary

Scientists are trying to identify drugs that can successfully treat breast cancer that has spread (metastasized) to the brain. Cabozantinib (Cometriq®) is used to treat metastatic thyroid cancer. It inhibits several different proteins that are involved in the growth and spread of the blood vessels tumors need to survive. Previous studies suggest it may be able to slow or stop the growth of metastatic breast cancer, including breast cancer that has spread to the brain. Trastuzumab (Herceptin®) is used to treat HER2+ breast cancer. This study is evaluating how well Cometriq works to treat breast cancer that has metastasized to the brain. In this study, patients who are HER2+ will also receive Herceptin.
This is a Phase II trial

AZD8835 in Advanced Breast (and Other Solid) Tumors

A Phase I, Open-Label, Multicentre, Dose-Escalation Study to Investigate the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours (NCT02260661)

Summary

AZD8835 is an investigational targeted therapy that is designed to block PI3K, a cell pathway that helps cancer cells grow. This study will look at the safety, efficacy and best dose of AZD8835 for ER+, HER2- breast cancer (and other solid tumors). This is the first study to give AZD8835 to humans. To take part in some aspects of this study, the patient will need to have a tumor that tests positive for the PIK3CA genetic mutation. Some parts of this study also require that postmenopausal patients be eligible for Fulvestrant (Faslodex®).
This is a Phase I trial

AZD5312 for Advanced Tumors Found to be Androgen Receptor Positive

A Phase I, Open-Label, Multicentre Dose-Escalation Study to Investigate the Safety and Pharmacokinetics of AZD5312 in Patients With Advanced Solid Tumours Where the Androgen Receptor Pathway is a Potential Factor (NCT02144051)

Summary

A number of cancers, including breast cancer, may be androgen receptor (AR) positive. AZD5312 has been shown to lower the levels of AR when tested in the laboratory. Researchers want to find out if blocking the androgen receptor will slow or stop tumor growth. This study will determine the best dose of AZD5312 to use in future studies. This is the first study to give AZD5312 to cancer patients.
This is a Phase I trial

Nivolumab Alone or Combined With Ipilimumab in Triple Negative Advanced Disease

A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors (NCT01928394)

Summary

Nivolumab is a new type of cancer drug called a PD-1 (Programmed Death receptor) inhibitor. It targets a protein that puts the brakes on the immune system. By gumming up these brakes, it allows the immune system to attack and kill cancer cells. Ipilimumab (Yervoy) is approved to treat metastatic melanoma. It attaches to a protein called CTLA-4, which also puts the brakes on the immune system. This study is investigating the safety and effectiveness of giving nivolumab alone or in combination with Yervoy to patients with triple negative breast cancer. (This study also is enrolling patients with gastric cancer, pancreatic adenocarcinoma, and small cell lung cancer.)
This is a Phase I-II trial

Abemaciclib for Hormone Receptor-Positive Brain Metastasis

A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer (NCT02308020)

Summary

Researchers are trying to develop therapies that will be effective in patients with hormone-sensitive breast cancer that has spread (metastasized) to the brain. Abemaciclib (LY2835219) is a new type of targeted therapy called a CDK 4/6 inhibitor. Previous studies suggest abemaciclib may be an effective treatment for hormone-sensitive metastatic breast cancer. This study will determine the safety and effectiveness of using abemaciclib to treat patients with hormone-sensitive breast cancer that has metastasized to the brain.
This is a Phase II trial

Herceptin® for HER2-Positive Metastases in Spinal Fluid

Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer (NCT01325207)

Summary

Leptomeningeal metastases (LM) occur when breast cancer spreads to the layers of tissue that cover the brain and spinal cord. LM are hard to treat because most cancer drugs cannot get into the spinal fluid that flows around these tissues. Trastuzumab (Herceptin®) is a targeted therapy used to treat HER2-positive breast cancer. The purpose of this trial is to determine the safety, maximum tolerated dose, and effectiveness of Herceptin when it is injected into the spinal fluid of patients with HER2-positive disease that has spread to the tissues covering the brain and spinal cord.
This is a Phase I-II trial

BBI608 and Taxol® for Advanced Disease

A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies (NCT01325441)

Summary

Cancer stem cells are thought to play a role in cancer growth and metastasis. Some researchers believe that cancer may return or progress when a cancer therapy does not kill the cancer stem cells. This is why scientists are trying to develop drugs that specifically target these cells. BBI608 is an experimental drug that researchers believe can inhibit cancer stem cells. The goal of this trial is to determine the safety and effectiveness of BBI608 when it is given with the chemotherapy drug paclitaxel (Taxol®) to individuals with metastatic breast cancer or locally advanced disease that cannot be removed by surgery.
This is a Phase I-II trial

CUDC-907 in Advanced Breast Cancer (And Other Solid Tumors)

Phase I Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, an HDAC and PI3K Inhibitor, in Subjects With Advanced/Relapsed Solid Tumors (NCT02307240)

Summary

Researchers are trying to develop new drugs that can be used to treat hormone sensitive (ER+/PR+) tumors that have stopped responding to the currently available hormone therapies. CUDC-907 is a targeted therapy that works by blocking HDAC and PI3K, two enzymes that play an important role in cell growth. This study will determine the best dose, safety and efficacy of CUDC-907 for treating women with advanced breast cancer. To be eligible, a woman must have HER2-negative breast cancer that has been treated with at least one hormonal therapy in the advanced/metastatic setting or that recurred during adjuvant (after surgery) therapy. This trial is also enrolling patients with other types of solid tumors.
This is a Phase I trial

PARP Inhibitor Veliparib for BRCA1/2 Metastatic Breast Cancer

A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 (NCT01506609)

Summary

Studies suggest that a class of drugs called PARP (poly ADP-ribose polymerase) inhibitors may be effective treatments for women who carry a BRCA1 or BRCA2 genetic mutation. The poly ADP-ribose polymerase (PARP) enzyme fixes DNA damage in both healthy and cancer cells. PARP inhibitors interfere with the PARP enzyme, which might make it even harder for cancer cells that have a BRCA1 or BRCA2 mutation to fix DNA damage. This trial is studying the efficacy and tolerability of veliparib, an investigational oral PARP inhibitor, in women with BRCA1/2-positive metastatic breast cancer.
This is a Phase II trial

GDC-0032 & Taxotere or Taxol in HER2-Negative Advanced Breast Cancer

A Phase Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0032 in Combination With Either Docetaxel or Paclitaxel in Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer (NCT01862081)

Summary

Researchers are studying the effectiveness of new drug combinations. GDC-0032 is a new type of drug called a PI3K-Inhibitor. These drugs block a cell pathway that plays a role in cancer cell growth. Docetaxel (Taxotere®) and paclitaxel (Taxol®) are chemotherapy drugs that are commonly used to treat breast cancer. This study is investigating the safety, tolerability, and best dose of GDC-0032 to use in combination with Taxotere or Taxol for treating patients with HER2-negative locally recurrent or metastatic breast cancer.
This is a Phase I trial

LEE011 in Premenopausal Women with Hormone-Sensitive HER2-Negative Advanced Breast Cancer

A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer (NCT02278120)

Summary

Researchers are studying new types of targeted therapies. LEE011 is a new targeted therapy that inhibits two enzymes--CDK4 and CDK6--that help tumors grow. Anastrozole (Arimidex®) and letrozole (Femara®) are two of the aromatase inhibitors (AIs) used to treat hormone-sensitive breast cancer in postmenopausal women. Premenopausal women can only use an AI if they also take a drug that will stop their ovaries from making estrogen. Goserelin (Zoladex®) is one of these drugs. Tamoxifen (Nolvadex®) is a hormone therapy used to treat hormone-sensitive breast cancer in pre- and post-menopausal women. In premenopausal women it can also be given with Zoladex. This study is comparing the effectiveness of giving a hormone therapy and Zoladex alone or with LEE011 to treat premenopausal women with hormone-sensitive HER2-negaitve advanced breast cancer.
This is a Phase III trial

AZD9496 in Patients with Advanced ER+, HER2- Breast Cancer

Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD9496 in Women With Estrogen Receptor Positive HER-2 Negative Advanced Breast Cancer (NCT02248090)

Summary

Researchers are developing new types of cancer treatments. AZD9496 is a new type of drug called a selective estrogen receptor degrader that "knocks down" the estrogen receptor. Laboratory studies suggest it may be effective in patients with hormone-sensitive tumors. The goal of this study is to determine the safety and best dose of AZD9496 for treating locally advanced or metastatic ER+, HER2- breast cancer. To be eligible, patients must have received or been offered all appropriate standard therapy. This study is the first to study AZD9496 in humans.
This is a Phase I trial

Panitumumab and Chemotherapy for Inflammatory Breast Cancer

Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression (NCT01036087)

Summary

Inflammatory breast cancer (IBC) is an aggressive type of advanced breast cancer. It is typically treated with chemotherapy prior to surgery. Panitumumab (Vectibix®) is a targeted therapy that works by preventing or slowing the growth of tumor cells by blocking proteins, called epidermal growth factor receptors, that are on the surface of cancer cells. Panitumumab is currently approved for the treatment of certain types of colorectal cancer, and researchers think it might also be effective for IBC. The goal of this trial is to study the safety and effectiveness of panitumumab when it is given with the chemotherapy drugs nab-paclitaxel (Abraxane®), carboplatin (Paraplatin®), fluorouracil (Adrucil®), epirubicin (Ellence®), and cyclophosphamide (Cytoxan®) before surgery to treat HER2-negative IBC.
This is a Phase II trial

LY3023414 for Advanced Breast (and other) Cancers

A Phase 1 First-in-Human Dose Study of LY3023414 in Patients With Advanced Cancer (NCT01655225)

Summary

LY3023414 is an experimental drug that researchers believe has the potential to be effective against breast and other cancers. The purpose of this first-in-human study is to identify a safe recommended dose level and schedule of dosing for LY3023414. The study will also explore what affect LY3023414 has on certain biological markers (biomarkers) associated with tumor growth, as well as on the cancer cells. To be eligible, participants must have already tried, or not be able to take, other available standard therapies. (This trial is also enrolling patients with advanced lymphoma and mesothelioma, and possibly other cancers as well.)
This is a Phase I trial

Vantictumab With Taxol in Advanced Breast Cancer

A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer (NCT01973309)

Summary

Cancer stem cells are the cancer cells that drive the tumor's growth. They create the cells that form the bulk of a tumor. Chemotherapy drugs are better at killing bulk tumor cells than they are at killing the cancer stem cells. Vantictumab is a new drug that is designed to target cancer stem cells. Paclitaxel (Taxol®) is a commonly used breast cancer treatment. This study will determine the best dose, safety, and tolerability of ventictumab when it is given with Taxol to treat patients with HER2-negative locally recurrent or metastatic disease.
This is a Phase I trial

Radiation and a Targeted Therapy to Treat Brain Metastases in HER2+ Patients

A Phase II Study of Stereotactic Radiosurgery Plus HER-2 Directed Therapy in HER2-positive Breast Cancer With Brain Metastasis (NCT01924351)

Summary

Brain metastases can cause pain and disturb brain function. Stereotactic radiosurgery is used to treat brain metastases as it can deliver targeted radiation to the tumors while protecting neighboring healthy brain tissue. This study is investigating if radiosurgery followed by a HER2 targeted therapy is effective for preventing disease progression in patients with HER2+ breast cancer that has spread to the brain. The HER2 targeted therapy will be selected by the physician and can include trastuzumab (Herceptin®), pertuzumab (Perjeta®), trastuzumab-emtansine (Kadcyla®), or lapatinib (Tykerb®).
This is a Phase II trial

LY2835219 Plus Faslodex For Advanced ER/PR Positive HER2 Negative Breast Cancer

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without LY2835219, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer (NCT02107703)

Summary

Researchers are studying new treatments for patients with tumors that are ER+ and/or PR+. (These tumors are also called hormone-receptor positive (HR+). LY2835219 (abemaciclib) is a new drug that keeps cancer cells from reproducing by blocking two kinases called CDK 4 and 6. Fulvestrant (Faslodex®) is a hormone therapy that is widely used to treat postmenopausal women with HR+ tumors that have stopped responding to other hormonal therapies. This study will compare the effectiveness of LY2835219 (abemaciclib) and Faslodex with Faslodex alone in postmenopausal patients with advanced HR+, HER2-negative breast cancer.
This is a Phase III trial

Faslodex & Taselisib in HER2- Tumors Previously Treated With an Aromatase Inhibitor

A PHASE III, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED STUDY OF TASELISIB PLUS FULVESTRANT VERSUS PLACEBO PLUS FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR-POSITIVE AND HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE DISEASE RECURRENCE OR PROGRESSION DURING OR AFTER AROMATASE INHIBITOR THERAPY (NCT02340221)

Summary

Over time, hormone-sensitive tumors can stop responding to hormone therapy. Fulvestrant (Faslodex®) is used to treat advanced hormone-sensitive breast cancer in postmenopausal women whose tumors have stopped responding to other hormone therapies. Taselisib (GDC-0032) is a new type of drug that selectively blocks the PIK3CA pathway, which plays a role in cell growth and survival. This study is comparing the safety and effectiveness of Faslodex and Taselisib to Faslodex and a placebo in postmenopausal women with ER+, HER2- advanced breast cancer whose tumors have recurred or progressed during or after aromatase inhibitor therapy. All women interested in this study will have their tumor tested for a PIK3CA mutation. Only those women who have a tumor that tests positive for the mutation will be eligible to receive study drugs.
This is a Phase III trial

Femara or Arimidex + Abemaciclib in Postmenopausal Women with HR+, HER2- Tumors

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With HR+, HER2- Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting. (NCT02246621)

Summary

Scientists are developing new types of cancer treatments. Abemaciclib (LY2835219) is a new type of drug called a CDK 4/6 inhibitor. Early studies suggest that abemaciclib may be effective in patients with hormone-sensitive tumors. Anastrozole (Arimidex®) and letrozole (Femara®) are aromatase inhibitors used to treat postmenopausal hormone-sensitive breast cancer. This trial is comparing the effectiveness of abemaciclib and Arimedex or Femara to a placebo and Arimidex or Femara in postmenopausal women with hormone-sensitive, HER2- metastatic breast cancer.
This is a Phase III trial

ANG1005 to Treat Brain Metastases

A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases (NCT02048059)

Summary

Researchers are trying to find new drugs that will be effective in patients with breast cancer that has spread to the brain (brain metastases). ANG1005 is a new drug that is composed of a protein molecule that has been attached to the chemotherapy drug paclitxel. Paclitaxel, like most chemotherapy drugs used to treat breast cancer, cannot cross the blood-brain barrier. ANG1005 connects to a specific place on the blood-brain barrier, allowing the paclitaxel to get through to the cancer cells. Early studies suggest that ANG1005 may be effective in breast cancer patients with brain metastases. This study is looking at the effectiveness of using ANG1005 to treat recurrent brain metastases in patients with breast cancer.
This is a Phase II trial

PD-0332991 & T-DM1 in Advanced HER2+ Tumors with the Rb Protein

Phase 1B Study of PD-0332991 in Combination With T-DM1 in the Treatment of Patients With Advanced HER2 (Human Epidermal Growth Factor Receptor 2)-Positive Breast Cancer (NCT01976169)

Summary

Researchers are looking for new ways to treat HER2+ breast cancer that has stopped responding to trastuzumab (Herceptin®) or other HER2-targeted therapies. PD-0332991 (Palbociclib) is a new targeted therapy that works by blocking two enzymes, CDK4 and CDK6, that play a role in cell growth. Studies suggest that palbociclib may be effective in tumors that test positive for a tumor suppressor protein called retinoblastoma (Rb). Scientists estimate that between 20% and 35% of breast cancers test positive for the Rb protein. T-DM1 (Kadcyla®) is a HER2-targeted therapy that combines the chemotherapy drug DM1 with trastuzumab. This study will identify the best dose of palbociclib to use along with T-DM1 to treat HER2-positive recurrent or metastatic breast cancer. To be eligible, participants must have a tumor that tests positive for the Rb protein.
This is a Phase I trial

Vaccine Plus Herceptin for HER2-Positive Breast Cancer

Combination Immunotherapy With Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-expressing Breast Cancer Patients to Prevent Recurrence (NCT01570036)

Summary

Researchers are investigating whether vaccines can play a role in cancer treatment. Trastuzumab (Herceptin®) is used to treat HER2-positive breast cancer. NeuVax® is a vaccine that uses the E75 peptide, which is a piece of the HER2 protein, to get the immune system to identify and kill HER2-positive cancer cells. GM-CSF is a substance added to the vaccine to improve the immune response. This trial will look at whether Herceptin along with the NeuVax vaccine is better than Herceptin alone at preventing recurrence in patients with stage I-III breast cancer who are at high risk for recurrence. To be eligible, participants must have breast cancer with tumors that express low (1+) or intermediate (2+) levels of HER2.
This is a Phase II trial

Radiation With or Without Tykerb® for HER2+ Brain Metastases

Whole-Brain Radiation Therapy With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer (NCT01622868)

Summary

Whole-brain radiotherapy is the most frequently used therapy for breast cancer brain metastases. This is because most chemotherapy drugs are not able to cross the blood-brain barrier. Lapatinib (Tykerb®) is a kinase inhibitor that targets HER2 as well as the epidermal growth factor receptor (EGFR). It is used with capecitabine (Xeloda®) to treat advanced HER2+ breast cancer in people who have already been treated with other chemotherapy drugs. It is unclear whether Tykerb is able to cross the blood-brain barrier. The purpose of this trial is to determine if whole-brain radiotherapy given along with Tykerb is more effective than whole-brain radiotherapy given alone.
This is a Phase II trial

BYL719 with Aromasin and/or Afinitor in Advanced Breast Cancer

A Phase Ib Dose-finding Study of BYL719 Plus Everolimus and BYL719 Plus Everolimus Plus Exemestane in Patients With Advanced Solid Tumors, With Dose-expansion Cohorts in Renal Cell Cancer (RCC), Pancreatic Neuroendocrine Tumors (pNETs), and Advanced Breast Cancer (BC) Patients. (NCT02077933)

Summary

Researchers are looking at the effectiveness of combining new targeted therapies with other types of breast cancer treatments. BYL719 is a new type of drug called a PI3K inhibitor. It is designed to slow or stop cancer cell growth by blocking the activity of the PI3K protein. Exemestane (Aromasin®) is an aromatase inhibitor that is routinely used to treat hormone-sensitive breast cancer. Everolimus (Afinitor®) is an mTOR inhibitor that is given along with Aromasin to treat advanced hormone-sensitive breast cancer. This study is designed to determine the highest dose and the safety of BYL719 when it is given with Afinitor or Afinitor and Aromasin to treat patients with advanced breast cancer who have no other standard treatments available. The study is also enrolling patients with advanced liver and pancreatic cancer.
This is a Phase I trial

CDX-011 or Xeloda for Advanced Triple Negative Breast Cancer

A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study) (NCT01997333)

Summary

Researchers are developing new types of targeted cancer treatments. Glembatumumab vedotin (CDX-011) is a new drug that targets a protein, called gpNMB, that helps tumors spread (metastasize) to other parts of the body. Early studies suggest CDX-011 may be effective in patients with triple-negative (ER, PR and HER2-negative) breast cancer. Capecitabine (Xeloda®) is a chemotherapy drug used to treat triple-negative breast cancer. This trial is comparing the safety and effectiveness of CDX-011 to Xeloda in patients with triple-negative breast cancer that has spread (metastasized) to other parts of the body. All patients who are interested in this study will have their tumor tested to determine its gpNMB status. Only those whose tumors test positive for gpNMB will be able to enter the study.
This is a Phase II trial

Using Genetic Mutations to Guide Treatment in Stage IV Tumors

Molecular Profiling-based Assignment of Cancer Therapy for Patients With Advanced Solid Tumors (NCT01827384)

Summary

Specific genetic variations or mutations inside a cancer cell can influence how it grows. The aim of "personalized" cancer treatment is to select the drugs that will work best based on the genetics of the patient's tumor. However, it is not yet known if this is a more effective approach. This study uses four cancer therapies, each of which targets a specific genetic mutation or variation---Everolimus/Afinitor (mTOR inhibitor), Trametinib DMSO (MEK inhibitor), Temozolomide and ABT-888 (PARP inhibitor), and Carboplatin and MK-1775 (Wee1 inhibitor). Patients with metastatic breast cancer will either be assigned to a drug based on their tumor's genetics, or assigned at random to one of these four drugs. This will allow the researchers to see if the personalized approach is safer and more effective. This study is also open to patients with other types of cancers.
This is a Phase II trial

Neratinib & Imodium after Herceptin for HER2+ Early Stage Breast Cancer

A Study Looking the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide (NCT02400476)

Summary

Neratinib is a targeted therapy that is currently being studied in clinical trials for HER2-positive breast cancer. These studies have found that diarrhea is one of the common side effects of neratinib. Loperamide (Imodium) is an over-the-counter medication used to prevent and treat diarrhea. This study is investigating whether women with HER2+ tumors who take Imodium along with neratinib experience less diarrhea. To be eligible, participants must have previously received trastuzumab (Herceptin®).
This is a Phase II trial

PF-06650808 For Previously Treated Metastatic Triple Negative Breast Cancer

A Phase 1 Dose Escalation Study Evaluating The Safety And Tolerability Of PF-06650808 In Patients With Advanced Solid Tumors (NCT02129205)

Summary

PF-06650808 is a new type of cancer drug that works by blocking the notch signaling pathway. Researchers think it may be effective for treating triple negative (ER-,PR-, HER2-) breast cancer because laboratory studies have shown that inhibiting notch signaling turns triple-negative tumors into more treatable estrogen-receptor positive cells. This study is evaluating the best dose and the effect of PF-06650808 in patients with previously treated metastatic triple negative breast cancer. It is also enrolling patients with other types of solid tumors. All patients interested in this trial will have their tumor tested to see if it expresses Notch3. Those whose tumors express Notch 3 will be eligible for the study.
This is a Phase I trial

Aromatase Inhibitor with Lapatinib and/or Herceptin®

Ph III Trial to Compare Safety and Efficacy of Lapatinib Plus Trastuzumab Plus Aromatase Inhibitor (AI) vs. Trastuzumab Plus AI vs. Lapatinib Plus AI as 1st Line in Postmenopausal Subjects With Hormone Receptor+ HER2+ MBC Who Received ... (NCT01160211)

Summary

Researchers are trying to determine the best treatment combination for postmenopausal women with hormone-sensitive, HER2+ metastatic breast cancer. Aromatase inhibitors (AIs) are used to treat hormone-sensitive tumors in postmenopausal women. Trastuzumab (Herceptin®) and lapatinib (Tykerb®) can each be used to treat advanced HER2+ tumors. The primary goal of this trial is to compare the effectiveness of an AI, Tykerb, and Herceptin to an AI and Herceptin or an AI and Tykerb. The trial will also look at the effect each combination has on quality of life.
This is a Phase III trial

Veliparib and Tykerb for Treating Triple Negative Metastatic Breast Cancer

An Open Label, Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative (ER, PR, and HER-2 Negative) Breast Cancer (NCT02158507)

Summary

Researchers are trying to find more effective treatments for triple-negative (ER-, PR-, HER2-) breast cancer. Veliparib (ABT-888) is a new type of cancer therapy called a PARP inhibitor. It works by blocking an enzyme that is needed for cancer cell growth. Lapatinib (Tykerb®) is used in combination with other drugs to treat HER2+ advanced breast cancer. Laboratory studies have shown that Veliparib and Tykerb can slow or stop the growth of triple negative breast cancer cells. This study is evaluating the safety and effectiveness of Veliparib and Tykerb in women with triple-negative metastatic breast cancer.

Chemotherapy & Herceptin Before Surgery for Stage I-III Tumors

A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients With Breast Cancer (NCT01750073)

Summary

Giving chemotherapy before surgery may make the tumor smaller, reducing the amount of tissue that needs to be removed during surgery. It also allows researchers to study how tumors respond to certain drugs. Paclitaxel (Taxol®) and cyclophosphamide (Cytoxan®) are two chemotherapy drugs that are routinely used to treat breast cancer. Trastuzumab (Herceptin®) is a targeted therapy that is used to treat HER2-positive breast cancer. This trial is studying the effectiveness of, and the side effects that occur when, giving Taxol and Cytoxan to patients with stage I-III breast cancer. Patients with HER2+ tumors will also receive Herceptin prior to surgery, so that the researchers can study a three drug combination—Taxol, Cytoxan, and Herceptin.
This is a Phase II trial

ARRY-380 and Herceptin for HER2+ Brain Metastases

Phase I Dose-escalation Trial of ARRY-380 in Combination With Trastuzumab in Participants With Brain Metastases From HER2+ Breast Cancer (NCT01921335)

Summary

Researchers are trying to identify cancer drugs that are able to cross the blood-brain barrier and could be used to treat brain metastases. Trastuzumab (Herceptin®) is used to treat HER2+ breast cancer, but cannot cross the blood brain barrier. ARRY-380 is a new HER2-targeted therapy that may be able to penetrate the blood-brain barrier. These drugs attach to different parts of the HER2 receptor and researchers think they may work well together. This study is testing the safety and effectiveness of different doses of ARRY-380 when it is given along with Herceptin to treat metastatic HER2+ breast cancer that has spread to the brain.
This is a Phase I trial

Dacomitinib in HER2+ Patients with Progressive Brain Metastases

A Phase II Study to Evaluate the Efficacy, Safety, and Central Nervous System (CNS) Pharmacokinetics of the HER Family Inhibitor Dacomitinib in Progressive Brain Metastases (NCT02047747)

Summary

It is difficult to treat brain metastases because most drugs are not able to cross the blood-brain barrier. Dacomitinib (PF-00299804) is a new drug that blocks epidermal growth factor receptors and tyrosine kinases. Early studies suggest it may be able to cross the blood-brain barrier. This study is looking at the safety and effectiveness of using dacomitinib to treat HER2+ breast cancer patients with progressive brain metastases. Patients with other types of cancers are also being enrolled in this study.
This is a Phase II trial

Keytruda with Herceptin or Kadcyla in Advanced Breast (and Other) Cancer

A Phase Ib/II Study of Pembrolizumab and Monoclonal Antibody Therapy in Patients With Advanced Cancer (PembroMab (NCT02318901)

Summary

Pembrolizumab (Keytruda®) is a new immunotherapy agent that works by blocking a protein called programmed cell death (PD-1) that normally keeps the body's immune system from attacking and destroying tumor cells. It has recently approved for treating metastatic melanoma and may also be effective in other types of cancer. Ado-trastuzumab ematansine/T-DM1 (Kadcyla®) is a HER2-targeted therapy that combines the chemotherapy drug DM1 with the HER2-targeted therapy trastuzumab (Herceptin®). In patients with HER2+ metastatic breast cancer, this study will compare the safety and effectiveness of Keytruda and Herceptin with Keytruda and Kadcyla. Patients with other types of cancers will be enrolled in different arms of the study.
This is a Phase I-II trial

FS102 for HER2-Positive Advanced Breast Cancer

Phase 1, Two-Part, Multiple, Ascending Dose Study of the Anti-HER2 FCAB FS102 in Breast, Gastric and Other Solid Tumors (NCT02286219)

Summary

Researchers are looking for new ways to treat HER2+ tumors. FS102 is a new targeted therapy that is designed to destroy HER2-positive cancer cells by directly binding to a unique site on the HER2 protein. This first-in-human study is designed to determine the safety, best dose and effect of FS102 when it is given to patients with HER2+ advanced breast cancer who have no other treatment options. (This study also is enrolling patients with other types of cancers that can be HER2+.)
This is a Phase I trial

Laboratory-Treated T Cells and Chemotherapy Before Surgery

Laboratory-Treated T Cells After Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer Undergoing Surgery (NCT01147016)

Summary

T cells are a type of white blood cell that help the body to fight off infection. Researchers believe that removing a patient's T cells, activating them in a laboratory by coating them with specific antibodies, and then putting them back into the body can teach the T cells how to kill tumor cells. Neoadjuvant therapy—treatment delivered prior to surgery—allows researchers to observe whether a tumor responds to a specific drug combination. Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®) followed by paclitaxel (Taxol®) is a standard chemotherapy regimen. The goal of this trial is to determine the effectiveness of giving this standard chemotherapy regimen and laboratory activated T-cells before surgery to women with stage II or III triple negative breast cancer.
This is a Phase II trial

RAD1901 for Advanced ER+ and HER2- Breast Cancer

A Phase I, Multicenter, Open-Label, Two-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer (NCT02338349)

Summary

Over time, hormone-sensitive tumors can stop responding to hormone therapy. Researchers are looking for ways to overcome this problem. RAD1901 is an investigational targeted therapy that is designed to prevent tumor growth by destroying the estrogen receptor (ER). This study is looking at the safety, efficacy and best dose of RAD1901 in post-menopausal women with advanced ER+, HER2- breast cancer. To be eligible, a patient must have received no more than two prior chemotherapy regimens and at least six months of hormone therapy.
This is a Phase I trial

Kadcyla™ vs Taxol & Herceptin for Stage I, HER2+ Breast Cancer

A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial) (NCT01853748)

Summary

Drugs that have been approved to treat metastatic breast cancer may also be effective in reducing the risk of recurrence in women with early-stage breast cancer. Trastuzumab emtansine (T-DM1/Kadcyla™) is a HER2-targeted therapy that was recently approved for the treatment of HER2+ metastatic breast cancer. Now, researchers are studying its use in the adjuvant (after surgery) setting to prevent recurrence. The HER2-targeted drug tastuzumab (Herceptin®) is currently used along with paclitaxel (Taxol®) to treat HER2+ early-stage breast cancer. This study is comparing the safety and effectiveness of Kadcyla to Herceptin and Taxol in women with stage I, HER2+ breast cancer.
This is a Phase II trial

PARP Inhibitor BMN 673 for Advanced Cancer in Patients with a BRCA Mutation

A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of BMN 673 Versus Physician's Choice in Germline BRCA Mutation Subjects With Locally Advanced and/or Metastatic Breast Cancer, Who Have Received No More Than 2 Prior Chemotherapy Re... (NCT01945775)

Summary

Researchers are trying to identify the best way to treat breast cancer in women who carry a BRCA mutation. Capecitabine (Xeldoa®), Eribulin (Halaven®), Gemcitabine (Gemzar®) and Vinorelbine (Navelbine®) are currently used to treat advanced breast cancer. BMN 673 is a new PARP inhibitor. It kills cancer cells by preventing PARP from repairing damaged DNA. Studies suggest that PARP inhibitors may be as or more effective than current treatments for patients with a BRCA mutation. This study is comparing the safety and effectiveness of BMN 673 to Xeloda, Halaven, Gemzar or Navelbline in patients who carry a BRCA mutation and have locally advanced or metastatic breast cancer. (Patients assigned to the control group will have their doctor determine if they should receive Xeloda, Halaven, Gemzar or Navelbline.)
This is a Phase III trial

A PI3K Inhibitor & Femara® Before Surgery in HR+, HER2- Tumors

A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer (NCT01923168)

Summary

Over time, cancer cells may stop responding to hormone therapy. Letrozole (Femara®) is a hormone therapy. BKM120 and BYL719 are PI3K inhibitors.They work by blocking the the PI3K pathway in cancer cells. Laboratory studies suggest blocking this pathway may get tumors to respond longer to hormone therapy. This study is looking at the effect that BKM120 and Femara; BYL719 and Femara; and Femara alone have on cancer cells in patients with early-stage ER+, HER2- tumors. Women interested in this trial will have their tumor tested for the PIK3CA mutation. Only those whose tumors test positive will be able to enroll in the study.
This is a Phase II trial

Erlotinib for Triple Negative Metastatic Disease

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab Followed by Bevacizumab and Erlotinib in Treating Patients With Metastatic Breast Cancer (NCT00733408)

Summary

Scientists are identifying specific proteins that help cancer cells grow and invade, in hopes of developing treatments that target these proteins. EGFR (epidermal growth factor receptor) is a protein found in high levels on the surface of many types of cancer cells including triple-negative breast cancer, and may contribute to abnormal cell growth. Researchers think that by interfering with EGFR, erlotinib (Tarceva®) may keep tumors from growing. This trial is evaluating erlotinib in combination with chemotherapy and bevacizumab (Avastin®), a drug that targets tumor blood vessel growth, in women with triple negative metastatic breast cancer. It is thought that the combination may provide more benefit than either drug alone.
This is a Phase II trial

Herceptin® and Everolimus for ER-Positive Metastatic Disease

Randomized Phase II of Trastuzumab With and Without Everolimus in Hormone-Refractory Metastatic Breast Cancer (NCT00912340)

Summary

There is currently no standard of care for treating hormone-sensitive breast cancer that has stopped responding to hormonal therapy. Trastuzumab (Herceptin®) is a targeted therapy that is used to treat tumors that produce large amounts of HER2. Everolimus (Afinitor®) is a new drug that was designed to block proteins that are important in the development and growth of cancer. Studies suggest it may be effective for treating HER2-positive tumors. Herceptin alone, or in combination with everolimus, has not been previously used to treat breast tumors that have small to moderate amounts of HER2 and have stopped responding to hormonal therapies. The purpose of the study is to find out if Herceptin alone or in combination with everolimus is an effective treatment for patients with metastatic breast cancer whose tumors have small to moderate amounts of HER2 and are no longer controlled by hormonal therapies.
This is a Phase II trial

PF-06647263 in Patients with Stage III or IV Breast Cancer (and Other Solid Tumors)

A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647263 In Adult Patients With Advanced Solid Tumors (NCT02078752)

Summary

PF-06647263 is a new type of targeted therapy called an antibody drug conjugate. These cancer treatments are designed to use a targeted therapy to deliver chemotherapy directly to the cancer cells. This study is investigating the safety and best dose of PF-06647263 for treating stage III or stage IV (metastatic) breast tumors (and other advanced solid tumors). To be eligible, a patient's tumor must be resistant to standard therapy or the patient must have no standard therapy available
This is a Phase I trial

Sirolimus and Metformin For Advanced Breast Cancer (and other Solid Tumors)

A Pharmacodynamic Study of Sirolimus and Metformin in Patients With Advanced Solid Tumors (NCT02145559)

Summary

Researchers are studying new cancer therapies. Metformin is widely used to treat type 2 diabetes. Previous research findings suggest that metformin may also be an effective cancer treatment. Scientists think metformin may kill cancer cells because it can block the mTOR protein, which plays a role in cell growth. Sirolimus (Rapamune) suppresses the immune system. It is used in combination with other medications to prevent rejection of kidney transplants. Laboratory studies show that sirolimus also targets the mTOR protein. This study is comparing the safety and effectiveness of two different ways of using sirolimus and metformin together to treat advanced breast cancer and other types of solid tumors.
This is a Phase I trial

MK-2206 & Arimidex Before Surgery for Stage II-III Tumors

A Phase II Trial of Neoadjuvant MK-2206 in Combination With Either Anastrozole if Postmenopausal or Anastrozole and Goserelin if Premenopausal in Women With Clinical Stage 2 or 3 PIK3CA Mutant Estrogen Receptor Positive, HER2 Negative... (NCT01776008)

Summary

Researchers are looking at the effectiveness of combining a targeted therapy with an aromatase inhibitor (AI). MK-2206 is a new targeted therapy that works by blocking Akt, a protein that helps tumors grow. Anastrozole (Arimidex®) is one of the AIs used to treat breast cancer. This trial is studying the effectiveness of and side effects associated with giving MK-2206 along with Arimidex to women with stage II or stage III breast cancer. Women who are premenopausal will also receive goserelin acetate (Zoladex®), a drug that temporarily shuts down the ovaries, allowing premenopausal woman to take an AI. If you are interested in the trial, your tumor will be tested to see if it has a PIK3CA mutation. To be eligible, participants must test positive for the PIK3CA mutation.
This is a Phase II trial

IMMU-132 for Metastatic Breast Cancer

A Phase I Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer (NCT01631552)

Summary

New treatments are needed for metastatic breast cancer. IMMU-132 is an experimental drug that combines a monoclonal antibody that binds to cancer cells with a chemotherapy agent. The chemotherapy agent is an active form of Irinotecan (Camptosar®), which is used to treat metastatic breast cancer and other types of cancers. Laboratory studies suggest that IMMU-132 maybe an effective way of delivering chemotherapy directly to breast cancer cells. (It is also being studied in 12 other types of cancers.) The purpose of this study is to test the safety of IMMU-132 at different dose levels.
This is a Phase I trial

Afinitor, Femara and Herceptin for Metastatic ER+, HER2+ Tumors

Combination Treatment With Everolimus, Letrozole and Trastuzumab in Hormone Receptor and HER2/Neu-positive Patients With Advanced Metastatic Breast Cancer and Other Solid Tumors: Evaluating Synergy and Overcoming Resistance (NCT02152943)

Summary

Researchers are studying new drug combinations for treating metastatic breast cancer. Letrozole (Femara®) is an aromatase inhibitor used to treat ER+ tumors. Everolimus (Afinitor®) is an mTOR inhibitor. It is used along with exemestane (Aromasin®) to treat postmenopausal women with advanced ER+, HER2- breast cancer. Trastuzumab (Herceptin®) is used to treat HER2+ tumors. This study will identify the highest dose of Femara that can be given along with Afinitor and Herceptin to postmenopausal women with metastatic ER+, HER2+ tumors and evaluate the safety of the drug combination. This study is also enrolling patients with other types of cancers.
This is a Phase I trial

GDC-0941 and Platinol For Triple Negative Metastatic Breast Cancer

A Phase Ib/II Trial of GDC-0941 (a PI3K Inhibitor) in Combination With Cisplatin in Patients With Androgen Receptor Negative Triple Negative Metastatic Breast Cancer (NCT01918306)

Summary

Researchers are looking for new ways to treat triple negative breast cancer. GDC-0941 is a new type of cancer therapy called a PI3K inhibitor. It works by blocking the PI3K pathway, which plays a role in tumor growth. Cisplatin (Platinol®) is a chemotherapy drug that is used to treat triple negative breast cancer. Laboratory studies suggest that giving a PI3K inhibitor such as GDC-0941 along with cisplatin may be an effective way to treat AR-negative, triple negative breast cancer. The first phase of this study will determine the maximum tolerated dose of GDC-0941 to use along with Platinol and the side effects associated with that dose. The second phase of the study will examine the safety and effectiveness of using GDC-0941 and Platinol for patients with triple negative breast cancer who also have low androgen receptor activity. All patients who are interested in this trial will have their tumor tested to for its androgen receptor (AR) status.
This is a Phase I-II trial

Personalized Gene-Based Treatment For Triple Negative Breast Cancer

A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer: Hoosier Oncology Group BRE12-158 (NCT02101385)

Summary

Researchers are trying to determine the best treatment for triple negative breast cancer. DNA from tumor samples collected at the time of surgery may provide information about which breast cancer treatments will work best on a specific tumor. Participants will have their tumors analyzed for 12 biomarkers or pathways found in breast cancer cells. One group will receive treatment based on the results. The other women will receive the standard of care. This will allow the researchers to compare therapy designed for each individual's tumor to the standard of care. To be eligible, participants must have had (or are planning to have) chemotherapy followed by surgery for breast cancer.
This is a Phase II trial

ONT-380 with Xeloda and/or Herceptin in HER2+ Metastatic Breast Cancer

A Phase 1b, Open-label Study to Assess the Safety and Tolerability of ONT-380 Combined With Capecitabine and Trastuzumab, Alone and in Combination in HER2+ Metastatic Breast Cancer (NCT02025192)

Summary

Researchers are studying new drugs as well as new drug combinations to determine the best treatment for HER2-positive metastatic breast cancer. ONC-380 is a new targeted therapy for HER2+ breast tumors. Laboratory studies suggest it may have fewer side effects than the HER2-targeted therapy trastuzumab (Herceptin®). Capecitabine (Xeloda®) is a chemotherapy drug used to treat metastatic breast cancer. This study is designed to determine the maximal tolerated dose of ONT-380 and to assess the safety and tolerability of combining ONT-380 with Xeloda, Herceptin, or Xeloda and Herceptin to treat patients with HER2+ metastatic breast cancer.
This is a Phase I trial

MGAH22 for HER2-Positive Metastatic Disease

A Phase 1, Dose Escalation Study of MGAH22 in Patients With Refractory HER2 Positive Breast Cancer and Patients With Other HER2 Positive Carcinomas for Whom No Standard Therapy Is Available (NCT01148849)

Summary

Trastuzumab (Herceptin®) is a breast cancer treatment that targets the HER2 protein. It is a type of drug called a monoclonal antibody, and it is used to treat both early-stage and metastatic HER2-positive tumors. Over time, though, HER2-positive tumors can stop responding to Herceptin®. As a result, researchers are trying to find other drugs that can be used to treat these tumors. MGAH22 is new monoclonal antibody that also targets the HER2 protein. The goal of this trial is to determine the safety, best dose, and effectiveness of MGAH22 when given to individuals with HER2-positive metastatic disease that has progressed on previous treatment and for whom no standard treatment is available.
This is a Phase I trial

Pazopanib, Pemetrexed and Crizotinib for Advanced Disease

A Two Steps Phase I Trial of Pazopanib or Pemetrexed in Combination With Crizotinib Followed by the Triplet, Crizotinib Plus Pazopanib Plus Pemetrexed in Patients With Advanced Malignancies (NCT01548144)

Summary

Using a combination of drugs may be more effective than using one drug alone for treating advanced breast cancer. Crizotinib (Xalkori) blocks a protein called ALK, which is involved in cancer cell growth and survival. It is approved to treat some types of non-small cell lung cancer. Pazopanib (Votrient) blocks the growth of blood vessels that supply nutrients needed for tumor growth. It is approved for the treatment of advanced kidney cancer. Pemetrexed (Alimta) blocks proteins that may cause tumors to grow. It is approved for the treatment of non-small cell lung cancer. The goal of this trial is to identify the highest tolerable dose and to study the safety of the combination of crizotinib and pazopanib; crizotinib and pemetrexed; and crizotinib, pazopanib and pemetrexed in patients with advanced breast cancer. Patients with other types of advanced cancer are also being enrolled in this study.
This is a Phase I trial

Faslodex +/- Afinitor for AI-Resistant Advanced Breast Cancer

Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) Plus Everolimus in Post-Menopausal Patients With Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy (NCT01797120)

Summary

Some patients with ER+ tumors do not respond to hormone therapy. Others have ER+ tumors that initially respond but, over time, become resistant. Fulvestrant (Faslodex®) is a hormone therapy that is commonly used when an ER+ tumor stops responding to an aromatase inhibitor (AI). Everolimus (Afinitor®) is an mTOR inhibitor. It is currently used along with the AI exemestane (Aromasin®) to treat advanced ER+, HER2- breast cancer. Using Afinitor along with Faslodex may be more effective than using Faslodex alone. This study is comparing the safety and effectiveness of Afinitor and Faslodex to Faslodex alone in women with advanced hormone-sensitive tumors who have already been on an AI.
This is a Phase II trial

VX-970 and Gemzar or Platinol in Patients with Advanced Triple Negative Breast Cancer

An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970 in Combination With Cytotoxic Chemotherapy in Subjects With Advanced Solid Tumors (NCT02157792)

Summary

Researchers are developing new types of cancer treatments. VX-970 is a targeted therapy that works by blocking the ATR protein, an enzyme that cells use to repair damaged DNA. Cisplatin (Platinol®) and Gemcitabine (Gemzar®) are two chemotherapy drugs routinely used to treat breast cancer. This study is designed to determine the safety and best dose of VX-970 when it is given along with Gemzar or Platinol to patients with locally advanced incurable or metastatic triple-negative breast cancer. This is the first study to test VX-970 study in humans. This study also is enrolling patients with other types of solid tumors. To be eligible, a patient must have already received a taxane-based chemotherapy regimen and have not had radiation or systemic therapy within last 4 weeks.
This is a Phase I trial

T-DM1 With Abraxane and Tykerb for HER2-Positive Metastatic Breast Cancer

Phase Ib Trial of Trastuzumab Emtansine In Combination With Lapatinib Plus Abraxane In Metastatic Her 2 Neu Over-Expressed Breast Cancer Patients (NCT02073916)

Summary

Researchers believe using a HER2-targeted drug along with other anti-cancer drugs may be a more effective way to treat HER2-positive metastatic breast cancer. Trastuzumab emtansine (T-DM1) is a HER2-targeted therapy used to treat metastatic HER2+ breast cancer. Nab-paclitaxel (Abraxane®) is an injectable form of paclitaxel (Taxol®) used to treat advanced breast cancer. Lapatinib (Tykerb®) is a type of targeted therapy called a tyrosine kinase inhibitor. It is used along with other drugs to treat advanced or metastatic breast cancer. Combining T-DM1, Abraxane and Tykerb may be an effective treatment for HER2+ metastatic breast cancer. This study will test the safety of T-DM1 in combination with different dose levels of Abraxane and Lapatinib in patients with HER2+ breast cancer.
This is a Phase I trial

GDC-0032 For Advanced Breast Cancer

An Open-Label, Phase I/II, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors and in Combination With Endocrine Therapy in Patients With Locally Advanced or ... (NCT01296555)

Summary

Over time, hormone-sensitive tumors can stop responding to hormone therapy. GDC-0032 is a new type of drug called a PI3-kinase inhibitor. It targets PI3 alpha, a protein found in about 40 percent of hormone sensitive breast tumors and that may be linked to hormone resistance. Fulvestrant (Faslodex) is used to treat postmenopausal women with hormone sensitive advanced breast cancer. In the first phase of this trial, the researchers will study the safety of GDC-0032. In the second phase, the researchers will study the safety and effectiveness of combining GDC-0032 and Faslodex. Both phases will enroll postmenopausal women with hormone-sensitive advanced breast cancer who have already been treated with hormone therapy.
This is a Phase I trial

Taxol, Herceptin & Perjeta Before Surgery for HER2+ IBC

Phase II Trial of Paclitaxel Combined With Trastuzumab and Pertuzumab as Pre-Operative Therapy for Inflammatory Breast Cancer (NCT01796197)

Summary

Researchers are studying new drugs and new treatment combinations for HER2+ Inflammatory Breast Cancer. Pertuzumab (Perjeta®) is used to treat HER2+ advanced breast cancer. It is a HER2-targeted therapy, like trastuzumaub (Herceptin®), but it attaches to a different part of the HER2 receptor. Studies suggest it may also be effective when used before surgery to treat HER2+ inflammatory breast cancer. Currently Paclitaxel (Taxol®) and trastuzumab are given before surgery to treat HER2+ inflammatory breast cancer. This study is investigating the safety and effectiveness of giving Perjeta along with Taxol and Herceptin before surgery to treat HER2+ inflammatory breast cancer.
This is a Phase II trial

MLN0128 With Hormone Therapy in ER+, HER2- Metastatic Breast Cancer

A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant (NCT02049957)

Summary

Targeted therapies called mTOR inhibitors are a new type of cancer treatment. Everolimus (Afinitor®) is an mTOR inhibitor. Exemestane (Aromasin®) is an aromatase inhibitor used to treat postmenopausal women. Fulvestrant (Faslodex®) is a hormone therapy used to treat women with hormone-sensitive tumors that have stopped responding to anti-estrogens. MLN0128 is a new mTOR kinase inhibitor that may work better than Afinitor. This study is investigating the safety and effectiveness of using MLN0128 along with Aromasin compared with using MLN0128 along with Faslodex to treat women with ER+, HER2- advanced breast cancer who have progressed on treatment with Afinitor in combination with Aromasin or Faslodex.
This is a Phase I-II trial

PF-05212384 + Other Drugs for Advanced ER+, HER2+ or Triple Negative Breast Cancer

A Phase 1B Open-Label Three-Arm Multi-Center Study To Assess The Safety And Tolerability Of PF-05212384 (PI3K/MTor Inhibitor) In Combination With Other Anti-Tumor Agents (NCT01920061)

Summary

Researchers are studying new drug combinations that could be used to treat advanced breast cancer. PKI-587 (PF-05212384) is a type of targeted therapy called an PI3K/mTOR inhibitor. It prevents cancer cells from growing by blocking PI3K and mTOR proteins. Docetaxel (Taxotere®) and cisplatin (Platinol®) are chemotherapy drugs that are routinely used to treat advanced breast cancer. Dacomitinib is a new type of HER2-targeted therapy that is currently being studied in clinical trials. This study is looking at the safety and effectiveness of using taxotere and PF-05212384 to treat advanced ER+ breast cancer; platinol and PF-05212384 to treat advanced triple negative breast cancer, and dacomitinb and PF-05212384 to treat advanced HER2+ breast cancer.
This is a Phase I trial

Denosumab for Disseminated Tumor Cells in Early Stage Cancer

Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer (UCSF Protocol No. 117527) (NCT01545648)

Summary

Studies have found that women with early stage breast cancer who have disseminated tumor cells (DTC) in the bone marrow are at increased risk of recurrence and death. Tests to detect DTC in women with early stage breast cancer may be helpful in identifying higher risk patients who might benefit from intervention with targeted therapies. Denosumab is used to treat osteoporosis and bone metastases. The researchers think that it also may be able to decrease DTC levels in women with early stage breast cancer who have completed chemotherapy. The purpose of this study is to see whether denosumab can reduce levels of DTC in the bone marrow below a significant level. To be eligible, participants must have DTC in the bone marrow following chemotherapy.
This is a Phase II trial

Xalkori and Sutent for HER2-Negative Metastatic Breast Cancer

A Phase IB Study of Crizotinib (XALKORI) and Sunitinib (SUTENT) in Metastatic Breast Cancer (NCT02074878)

Summary

Targeted therapies used to treat other types of cancers may also be effective breast cancer treatments. Crizotinib (Xalkori®) is a targeted therapy used to treat metastatic non-small cell lung cancer in patients whose tumors have an ALK mutation. Sunitinib (Sutent®) is used to treat pancreatic cancer. It blocks tumors from growing the new blood vessels they need to survive. This study is designed to determine the safety, best dose, and tolerability of using Xalkori and Sutent together to treat patients with HER2-negative metastatic breast cancer. To be eligible, patients must have already had two types of systemic therapy for breast cancer. Patients whose tumors are hormone sensitive (ER+ and/or PR+) must have already had their metastatic breast cancer treated with one hormonal therapy and one chemotherapy.
This is a Phase I trial

Herceptin in HER2-Negative Stage II/III Breast Cancer w/ HER2+ Disseminated Tumor Cells

A Phase II Randomized Trial Evaluating the Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Bone Marrow Disseminated Tumor Cells (NCT01779050)

Summary

Breast cancer patients who are found to have tumor cells in their bone marrow (known as disseminated tumor cells or DTCs) are at greater risk of a recurrence than patients without DTCs. Trastuzumab (Herceptin®) is used to treat HER2-positive breast cancer. However, some patients with HER2-negative tumors may have HER2-positive DTCs and may benefit from Herceptin therapy. ACT (doxorubicin/adriamycin, cyclophosphamide and Taxol) is a chemotherapy regimen used to treat breast cancer. This trial is comparing the safety and effectiveness of using Herceptin with ACT to using ACT alone to treat patients with stage II-III HER2-negative breast cancer who have been shown to have HER2-positive DTCs in their bone marrow.
This is a Phase II trial

Pazopanib, Paclitaxel & Carboplatin for Advanced Breast Cancer

Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors (NCT01407562)

Summary

Pazopanib (Votrient®) is a targeted therapy that works by inhibiting vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit—proteins that help tumors grow and survive. Pazopanib has been approved for the treatment of kidney cancer, and researchers are currently investigating whether it may be effective in certain other cancers as well. Paclitaxel (Taxol®) and carboplatin (Paraplatin®) are two chemotherapy drugs routinely used to treat advanced breast cancer. The goal of this study is to determine the safety, tolerability, and maximum tolerated dose of pazopanib when it is combined with weekly paclitaxel and carboplatin in patients with advanced breast cancer.
This is a Phase I trial

A PI3K-inhibitor (CLR457) for Advanced Breast Cancer (And Other Solid Tumors)

A Phase I/II Multicenter, Open-label Study of CLR457, Administered Orally in Adult Patients With Advanced Solid Malignancies (NCT02189174)

Summary

Researchers are looking for more effective cancer treatments. CLR457 is a new type of breast cancer drug called a PI3K-inhibitor. It works by blocking the PI3K cell pathway, which plays a role in cancer cell growth. This study will identify the best dose and anti-tumor activity of CLR457. This study is open to patients with advanced breast cancer. It is also enrolling patients with other types of solid tumors. All patients interested in the study will have their tumor tested for a PIK3CA mutation, a PTEN deficiency, an EGFR mutation, cMET activation and HER2 status to see if they are eligible for the study.
This is a Phase I-II trial

Imbruvica and MEDI4736 in Advanced HER2+ or Triple Negative Breast Cancer

A Multi-Center Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With MEDI4736, in Subjects With Relapsed or Refractory Solid Tumors (NCT02403271)

Summary

Researchers are studying the effectiveness of combining a targeted therapy with an immunotherapy. Ibrutinib (Imbruvica®) is a targeted therapy that is used to treat lymphoma and leukemia. Early studies suggest it may also be effective in breast cancer. MEDI4736 is a type of immunotherapy drug called a PD-1 inhibitor. It works by blocking a signaling pathway that some tumors use to avoid being attacked by the immune system. This study is looking at the safety and efficacy of using Imbruvica and MED14736 to treat advanced HER2-positive or triple negative breast cancer. To be eligible, a breast cancer patient must have progressed on at least two prior treatments. (The study also is enrolling patients with advanced pancreatic or non-small cell lung cancer.)
This is a Phase I-II trial

Neratinib For HER2-Negative Metastatic Breast Cancer

A Phase II Study of Neratinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer (NCT01670877)

Summary

About 25 percent of women with breast cancer have tumors that have a genetic mutation that causes the cancer cells to have too many copies of the HER2 gene and too many HER2 receptors. These tumors are called HER2-positive, and they can be treated with the anti-HER2 targeted therapies Herceptin and Tykerb. Scientists recently discovered that some HER2-negative tumors have other types of HER2 genetic mutations that might make them respond to anti-HER2 targeted therapies. Neratinib is a new targeted therapy being developed to treat HER2-positive tumors. Researchers think it may also be effective in women whose tumors are HER2-negative but have these newly discovered HER2 mutations. The purpose of this study is to evaluate Neratinib in patients with metastatic breast cancer whose tumors are HER2-negative but have these HER2 mutations. Patients who meet the entry criteria for this study will have their tumor tested for HER2 mutations. Only those who are found to have a HER2 mutation will be able to take part in the study.
This is a Phase II trial

Digoxin in Newly Diagnosed Operable Breast Cancer

Digoxin as a Novel Inhibitor of Global Hypoxia Inducible Factor-1α (HIF-1α) Expression & Downstream Targets in Breast Cancer: DIG-HIF1 Pharmacodynamic Trial (NCT01763931)

Summary

Breast cancer cells grow in a low oxygen environment called hypoxia. The protein HIF-1 controls the amount of oxygen in the body's cells. Researchers think blocking HIF-1 may make it harder for breast cancer cells to grow. Digoxin is a drug that has been shown to block HIF-1 in lab studies. (It is currently used to help the heart work better and to control heart rate.) The purpose of this study is to learn what effects digoxin may have on breast tumors. This will be done by comparing tumor tissue from a woman's original biopsy with tumor tissue removed at the time of surgery, after she has been on digoxin for two weeks. The researchers will also compare biopsy and surgery tissue from women not given digoxin with that of the women who did take it.
This is a Phase II trial

Perjeta, Herceptin and Chemo Before Surgery for HER2-Positive Breast Cancer

Single Arm, Neoadjuvant, Phase II Trial of Pertuzumab and Trastuzumab Administered Concomitantly With Weekly Paclitaxel and FEC for Clinical Stage I-II HER2-Positive Breast Cancer (NCT01855828)

Summary

Giving therapy before surgery (called neoadjuvant treatment) allows researchers to study the effect that a drug combination has on cancer cells. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2+ tumors. T-FEC is a chemotherapy regimen used to treat breast cancer. "T" refers to paclitaxel (Taxol®), which is given first and then followed by FEC (5-fluorouracil, epirubicin and cyclophosphamide). Herceptin is often given with T-FEC. This study is investigating the effectiveness of adding Perjeta to Herceptin and T-FEC by giving it before surgery to women with stage I - III HER2+ breast cancer.
This is a Phase II trial

Xofigo, Xgeva & Hormone Therapy to Treat ER+ Bone Metastases

Phase II Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer (NCT02366130)

Summary

Researchers are trying to find ways to effectively treat ER+ breast cancer that has spread (metastasized) to the bone. Ra-223 dicholoride (Xofigo®) uses radioactive particles that mimic calcium to enter the bone and target cancer cells. It is approved to treat bone metastases in prostate cancer. Denosumab (Xgeva®) is used in patients with bone metastases to prevent fractures, spinal cord compression, or the need for bone radiation or surgery. Tamoxifen, aromatase inhibitors, and fulvestrant (Faslodex®) are hormone therapies used to treat hormone-sensitive metastatic breast cancer. This study will determine the safety and effectiveness of giving Xofigo, Xgeva and a hormone therapy (selected by the doctor) to treat bone metastases in women with ER+ breast. To be eligible, a patient must have had no prior or only one prior treatment for metastatic breast cancer and must have a metastatic site biopsied to confirm it is ER+.
This is a Phase II trial

PM01183 for Metastatic Breast Cancer

A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer (NCT01525589)

Summary

Researchers are studying new drugs that may be effective in treating metastatic breast cancer. Laboratory studies suggest that PM01183, a drug that promotes cancer cell death by binding to specific pieces of DNA, may be an effective cancer therapy. This study is looking at whether PM01183 is effective in women with metastatic breast cancer, and whether women who carry a BRCA 1/2 genetic mutation are more likely to respond to this drug. To be eligible for "Group A", a patient must have a known BRCA 1/2 mutation. Patients who do not have a BRCA1/2 mutation may be eligible for "Group B."
This is a Phase II trial

BAY1125976 For Advanced Breast Cancer (and other solid tumors)

A Phase I, Multi-center, Non-randomized, Open-label, Dose Escalation Design Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY 1125976 in Subjects With Advanced Solid Tumors (NCT01915576)

Summary

BAY1125976 is a new type of targeted therapy called an AKT 1/2 inhibitor. Laboratory studies have shown that BAY1125976 can slow or stop tumor cell growth. This is the first study where BAY1125976 is given to cancer patients. Initially, BAY1125976 will be given to any cancer patient who has run out of treatment options so researchers can determine the best study dose. Once the dose is established, researchers will continue to study BAY1125976, but in breast cancer patients only. A tumor does not have to test positive for the AKT1 mutation for a patient to enroll in this study. The goal of this study is to determine the safety and best dose of BAY1125976 as a cancer treatment.
This is a Phase I trial

Tetrathiomolybdate (TM) for Stage II, III, and IV Breast Cancer

A Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer at Moderate to High Risk of Recurrence (NCT00195091)

Summary

Scientists are trying to develop new treatments for preventing recurrence of primary breast cancer or progression of advanced disease. Studies have shown that tumors need copper to grow new blood vessels, a process called angiogenesis. Tetrathiomolybdate (TM) is a drug that is currently being studied in clinical trials that is able to decrease copper levels in the body. This, in turn, may keep tumors from growing and spreading. The purpose of this trial is to assess the safety and effectiveness of TM in women with Stage II, III, or IV breast cancer. Note: Participants who are stage IV must have no evidence of disease.
This is a Phase II trial

First Study of AZD8186 in Patients

A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD8186 in Patients With Advanced Castrate-resistant Prostate Cancer (CRPC), Squamous Non-Small Cell Lung Cancer (sqNSCLC), Triple Negative Breast Cancer (TNBC)... (NCT01884285)

Summary

AZD8186 is a new cancer therapy that works by inhibiting PI3K, a group of proteins that help cancer cells to grow. It is designed specifically for cancers that are characterized as being deficient in PTEN, a gene that regulates cell growth. The purpose of this study is to determine the safest, best dose of AZD8186 in PTEN-deficient cancers. This trial is enrolling individuals with triple negative breast cancer as well as other cancers.
This is a Phase I trial

ABBV-221 for Advanced Tumors That Are EGFR-Positive

A Phase 1 Study of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor (NCT02365662)

Summary

The epidermal growth factor receptor (EGFR) is found on the surface of many types of cancer cells. Triple negative (ER-, PR- and HER2-) breast tumors are likely to exhibit higher levels of EGFR. Researchers think that these high levels of EGFR may help fuel the cancer cell's growth. ABBV-221 is a new type of targeted therapy, delivered by IV, that is designed to block the EGFR receptor. This study will determine the safety and best dose of ABBV-221 when it is used to treat advanced triple-negative breast cancer (and other solid tumors) that are EGFR-positive.
This is a Phase I trial

KD019 and Herceptin® for HER2-Positive Metastatic Breast Cancer

A Phase 1b/2a Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer (NCT02154529)

Summary

HER2-positive breast cancer frequently metastasizes (spreads) to the brain. Metastasis to the brain is difficult to treat because most chemotherapy drugs are unable to cross the blood-brain barrier (BBB). Trastuzumab (Herceptin®) is routinely used to treat HER2-positive breast cancer; it cannot cross the BBB. KD019 is an investigational drug that studies suggest can target HER2 and cross the BBB. This study is assessing the safety, tolerability, and maximum tolerated dose of KD019 when given with Herceptin to treat women with HER2-positive metastatic breast cancer.
This is a Phase I-II trial

LEE011, Afinitor & Aromasin in ER+ HER2- Advanced Breast Cancer

A Phase Ib/II Trial of LEE011 in Combination With Everolimus (RAD001) and Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive, Her2- Locally Advanced or Metastatic Breast Cancer (NCT01857193)

Summary

LEE011 is a new oral drug that targets two enzymes--CDK4 and CDK6--that play a role in cell growth. Laboratory studies suggest LEE011 can slow or stop the growth of cancer cells. Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. Exemestane (Aromasin®) is used to treat hormone-sensitive tumors. Afinitor is used along with Aromasin to treat ER+, HER2- advanced breast cancer. This study is comparing the safety and tolerability of using the combination of LEE011, Afinitor, and Aromasin, or the combination of LEE011 and Aromasin, to the safety and tolerability of Afinitor and Aromasin in women ER+, HER2- advanced breast cancer.
This is a Phase I-II trial

Kadcyla + Perjeta vs Herceptin + Perjeta + Chemo Before Surgery in HER2+ Breast Cancer

A RANDOMIZED, MULTICENTER, OPEN-LABEL, TWO-ARM, PHASE III NEOADJUVANT STUDY EVALUATING TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB COMPARED WITH CHEMOTHERAPY PLUS TRASTUZUMAB AND PERTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER (NCT02131064)

Summary

Giving therapy before surgery (neoadjuvant treatment) allows researchers to study the effect that a drug combination has on cancer cells. Kadcyla® (trastuzumab emtansine) is used to treat HER2+ metastatic breast cancer. It combines the chemotherapy drug DMI with trastuzumab (Herceptin®). Perjeta® (pertuzumab) and Herceptin® are targeted therapies used to treat HER2+ breast cancer. Docetaxel (Taxotere®) and carboplatin (Paraplatin®) are chemotherapy drugs used to treat HER2+ breast cancer. This study is comparing the effect of Kadcyla and Perjeta to the effect of Herceptin, Perjeta, Taxotere and Paraplatin on cancer cells when it is given before surgery to women with HER2+ breast cancer.
This is a Phase III trial

POL6326 and Halaven for HER2- Metastatic Breast Cancer

A Phase I Dose Escalation Study of POL6326 With Eribulin in Patients With Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer (NCT01837095)

Summary

POL6326 is a new type of drug called a CXCR4 inhibitor. It blocks proteins that help cancer cells spread to and survive in other parts of the body. Eribulin (Halaven®) is a chemotherapy drug used to treat advanced breast cancer that has not responded to or has stopped responding to other chemotherapy drugs. This trial is studying the safety and tolerability of different doses and dosing frequencies of POL6326 in combination with Halaven in patients with HER2-negative metastatic breast cancer. To be eligible for this trial, a patient must have tried at least two but no more than three chemotherapy regimens for metastatic cancer and have been treated with an anthracycline and taxane in either the adjuvant or metastatic setting.
This is a Phase I trial

BAY1187982 for Metastatic Tumors That Are FGFR2-Positive

Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2) (NCT02368951)

Summary

Researchers are developing new types of targeted therapies to treat cancers that have spread (metastasized) to other parts of the body. The fibroblast growth factor receptor 2 (FGFR2) protein helps fuel the growth of cancer cells. BAY1187982 is a new type of targeted therapy designed to blocks the FGFR2 receptor. Laboratory and early studies suggest blocking this receptor may slow or stop cancer cell growth. This study is investigating the safety, effectiveness and best dose of BAY1187982 when it is used to treat patients with advanced breast cancer who have progressed on other cancer therapies and whose tumors test positive for FGFR2. This trial also is enrolling patients with other types of metastatic solid tumors. All patients interested in the trial will have their tumor tested for FGFR2. (Only those whose tumors test positive will be able to enroll in the study.)
This is a Phase I trial

First-In-Human Study of MORAb-066 for Metastatic Breast Cancer

A Phase I Study of the Safety, Tolerability, and PK of MORAb-066, a Humanized Monoclonal Antibody to Human TF, in Patients With Advanced or Metastatic Breast, Pancreatic, Colorectal, or NSCLC (Adenocarcinoma) Malignancies (NCT01761240)

Summary

New treatments are needed for metastatic breast cancer. MORAb-066 is an investigational targeted therapy that may be an effective breast cancer treatment. It works by targeting a tissue factor protein that studies suggest may help tumors grow and spread. This first-in-human study will assess the safety, tolerability, and activity of MORAb-066 and determine the maximum tolerated weekly dose in women with metastatic breast cancer. (This study also is enrolling patients with pancreatic, colorectal, and non-small-cell lung cancer.)
This is a Phase I trial

PF-03084014 With Docetaxel In Advanced HER2-Negative Breast Cancer

Phase 1B Study Of Docetaxel + PF-03084014 In Metastatic Or Locally Recurrent/Advanced Triple Negative Breast Cancer (NCT01876251)

Summary

Scientists are developing new types of breast cancer treatments. PF-03084014 is a new type of cancer drug called a selective gamma secretase (GS) inhibitor. These drugs are able to inhibit a signaling pathway called Notch, which plays a role in cancer cell growth and survival. Blocking the pathway may slow or stop cancer cell growth. Docetaxel (Taxol®) is a chemotherapy drug that is commonly used to treat breast cancer. This study will investigate the side effects associated with giving PF-03084014 along with Taxol to patients with advanced breast cancer. The researchers will also collect data that will help them begin to study whether the drug combination is effective. To be eligible, participants must have triple negative breast cancer or hormone-sensitive breast cancer that has progressed on hormone therapy.
This is a Phase I trial

MM-302 Plus Herceptin For Previously Treated HER2-Positive Advanced Breast Cancer

A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer (NCT02213744)

Summary

Researchers are trying to develop less toxic ways to use effective chemotherapy drugs. MM-302 is a targeted therapy that delivers the chemotherapy drug doxorubicin directly to HER2+ cells. By delivering doxorubicin directly to the cancer cells, researchers believe the drug will cause fewer side effects and less damage to the heart. Trastuzumab (Herceptin®) is used to treat HER2+ tumors. This trial is comparing the safety and effectiveness of MM-302 and Herceptin to chemotherapy and Herceptin in patients with HER2+ advanced breast cancer who were previously treated with Herceptin, who have either progressed on or cannot take pertuzumab (Perjeta®) and ado-trastuzumab emtansine (Kadcyla®) and have not been previously treated with doxorubicin or other anthracyclines.
This is a Phase II-III trial

AMP-514 For Patients with Advanced Breast Cancer

A Phase 1, Multi-Center, Open-label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMP-514 in Subjects With Advanced Solid Malignancies (NCT02013804)

Summary

Scientists are developing new types of targeted therapies. AMP-514 is a monoclonal antibody that targets a protein called PD-1. In laboratory studies, the drug kills cancer cells. In this clinical trial, the drug will be given to humans for the first time. To be eligible, patients must have advanced breast cancer that has stopped responding to treatment or have no standard treatment available to them. This study also is enrolling patients with other types of advanced solid tumors.
This is a Phase I trial

Romidepsin for Patients with Breast Cancer & Liver Dysfunction

A Phase 1 and Pharmacokinetic Single Agent Study of Romidepsin in Patients With, Lymphomas, Chronic Lymphocytic Leukemia and Select Solid Tumors and Varying Degrees of Liver Dysfunction (NCT01638533)

Summary

Targeted therapies are being developed that may be effective against many different types of tumors, including breast cancer. Romidepsin (Istodax®) is an HDAC inhibitor. It works by entering cancer cells and blocking the activity of proteins, called histone deacetylases, that are important for the cancer's growth and survival. Romidepsin was approved in November 2009 for the treatment of cutaneous T-cell lymphoma. Since then, researchers have conducted studies to see if it might also be effective in patients with other types of cancer. This study is evaluating the safety of different dose levels of romidepsin in cancer patients with varying degrees of abnormal liver function. To be eligible, patients must have breast cancer (or lymphoma, chronic lymphocytic leukemia, or other certain solid tumors for which standard treatment is no longer effective) and be experiencing liver dysfunction.
This is a Phase I trial

Tykerb, Afinitor & Xeloda for HER2+ Brain Metastases

Phase 1b/2 Single-arm Trial Evaluating the Combination of Lapatinib, Everolimus and Capecitabine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer With CNS Progression After Trastuzumab (NCT01783756)

Summary

Breast cancer that has metastasized (spread) to the brain is difficult to treat because most cancer drugs are unable to cross the blood-brain barrier. Lapatinib (Tykerb®) is currently used along with capecitabine (Xeloda®) to treat advanced HER2+ breast cancer. Everolimus (Afinitor®) is currently used along with exemestane (Aromasin®) to treat advanced hormone-sensitive breast cancer. Both Tykerb and Afinitor are able to cross the blood-brain barrier. Researchers believe that using Tykerb, Xeloda, and Afinitor at the same time may be an effective way to treat HER2+ brain metastases. This study will evaluate the safety and effect that the combination of Tykerb, Xeloda, and Afinitor have on women whose tumors are HER2+, have brain metastases, and have already been treated with trastuzumab (Hercepin®).
This is a Phase I-II trial

BAY1217389 and Taxol for Advanced Breast Cancer

An Open-label Randomized Two-arm Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of Oral BAY 1217389 in Combination With Weekly Intravenous Paclitaxel Given in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies (NCT02366949)

Summary

BAY1217389 is a new type of cancer drug called an MPS1 inhibitor. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat advanced breast cancer. Laboratory studies suggest that giving BAY1217389 with Taxol may improve Taxol's effectiveness and keep cancer cells responding to Taxol longer. This study will determine the best dose, safety, and tolerability of BAY1217389 when it is given with Taxol to patients with advanced breast cancer. (This trial is also enrolling patients with other types of advanced cancer for the first part of the trial and patients with triple negative breast cancer for the second part of the trial.) To be eligible, a patient must have no standard therapy available.
This is a Phase I trial

A New Approach to Studying HER2+ Targeted Therapies

Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib (NCT01875666)

Summary

Researchers are looking for ways to determine which HER2-targeted therapies are most effective for which patients. They also want to learn more about what makes a cancer cell stop responding to a HER2-targeted therapy. Kinases are a group of proteins that are important in how cancer cells grow. HER2 is a kind of kinase. Giving drugs before surgery--called neoadjuvant treatment--allows researchers to study how cancer cells respond to the treatment. In this study, trastuzumab (Herceptin®); pertuzumab (Perjeta®); Herceptin and Perjeta; and Herceptin and lapatinib (Tykerb®) will be given before surgery to patients to study the effect they have on kinases in cancer cells. To be eligible, participants must be newly diagnosed and planning on having surgery for breast cancer.
This is a Phase I trial

Comparing PF-05280014 & Chemo to Herceptin & Chemo Before Surgery for HER2+ Breast Cancer

A Randomized, Double-blind Pharmacokinetic Study Of Pf-05280014 Plus Taxotere (Registered) And Carboplatin Versus Herceptin (Registered) Plus Taxotere (Registered) And Carboplatin For The Neoadjuvant Treatment Of Patients With Operable Her2-positive Breast Cancer (NCT02187744)

Summary

Companies are developing therapies designed to be biosimilar to the HER2-targeted therapy trastuzumab (Herceptin®). PF-05280014 is one of these biosimilar therapies. Docetaxel (Taxotere®) and carboplatin (Paraplatin®) are chemotherapy drugs commonly used to treat breast cancer. Giving treatment before surgery, called neoadjuvant therapy, allows researchers to study the effect that a drug has on the tumor. This study is comparing the safety and efficacy of PF-05280014, Taxotere and Paraplatin to Herceptin, Taxotere and Paraplatin when given before surgery to patients with stage I-III HER2+ breast cancer.
This is a Phase III trial

Personalized Treatment Before Surgery: The I-SPY 2 Trial

I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) (NCT01042379)

Summary

Targeted therapy is an active area of breast cancer research in which treatment is tailored to an individual's tumor type. The goal of this trial is to determine whether standard chemotherapy can be made more effective by adding investigational drugs that target specific tumor characteristics. All treatment will be given prior to surgery (neoadjuvant therapy), enabling researchers to directly evaluate how well the tumor is responding. The information that researchers gain from each participant will be used to help decide which treatments should be given to women who join the trial at a later date. By designing the trial in this way, researchers will learn more quickly which investigational drugs will be most beneficial for women with certain tumor characteristics.
This is a Phase II trial

Afinitor and an Anti-Estrogen Therapy for ER/PR+, HER2- Advanced Breast Cancer

Phase II Open Label Study of Everolimus in Combination With Anti-estrogen Therapy in Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer (NCT02291913)

Summary

Everolimus (Afinitor®) is a new type of targeted therapy called an mTOR inhibitor. It is used to treat advanced hormone-sensitive, HER2- breast cancer along with the anti-estrogen therapy exemestane (Aromasin®) in postmenopausal women who have already received certain other treatments. Researchers believe this treatment works in part because it gets the cancer cells to start responding again to the anti-estrogen therapy. It is not known whether Afinitor will get tumors to start responding again to other anti-estrogen therapies. In this study patients will receive Afinitor along with the anti-estrogen therapy they were taking when their cancer progressed. (The anti-estrogen therapy can be tamoxifen, fulvestrant/Faslodex®, anastrozole/Arimidex®, letrozole/Femara®, exemestane/Aromasin®, toremifene/Fareston®, or an LHRH agonist given with anti-estrogen therapy).
This is a Phase II trial

PD 0332991 & Arimidex Before Surgery for ER+, HER2- Tumors

A Phase II Trial of Neoadjuvant PD 0332991, a Cyclin-Dependent Kinase (Cdk) 4/6 Inhibitor, in Combination With Anastrozole in Women With Clinical Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer (NCT01723774)

Summary

PD 0332991 (palbociclib isethionate) is a new oral drug that works by blocking a family of enzymes that control cell division. Anastrozole (Arimidex®) is used routinely to treat hormone-sensitive tumors. Giving anti-cancer medications before surgery (neoadjuvant treatment) allows researchers to see how the tumor responds to the drugs being studied. The goal of this trial is to investigate the safety and effectiveness of giving PD 0332991 along with Arimidex before surgery to women with stage II or stage III ER+, HER2- breast cancer. To be eligible, participants must have tested negative for the PIK3CA mutations.
This is a Phase II trial

SGN-LIV1A in HER2-Negative Metastatic Breast Cancer

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With LIV-1-Positive Metastatic Breast Cancer (NCT01969643)

Summary

Antibody-drug conjugates (ADCs) are cancer therapies that combine an antibody that targets cancer cells with a drug that can kill cancer cells. Because the antibody only targets cancer cells, the drug does not kill normal cells, making it less likely to cause side effects. SGN-LIV1A is an ADC that targets LIV-1 (SLC39A6), a protein that is expressed by most breast cancer cells, and delivers a cancer drug called monomethyl auristatin E. This study will assess the safety, highest tolerable dose and anti-tumor activity of SGN-LIV1A in patients with HER2-negative metastatic breast cancer. To be eligible, patients must have triple negative metastatic breast cancer or HER2-negative, hormone sensitive metastatic breast cancer that can no longer be treated with a hormone therapy.
This is a Phase I trial

Targeted Therapies Plus Chemo Before Surgery For ER+, HER2+ Breast Cancer

Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Taxotere, Trastuzumab and Pertuzumab) in Patients With HER2-positive and ER-Positive Breast Cancer (NeoHTTP Study) (NCT02345772)

Summary

Giving therapy before surgery -- called neoadjuvant treatment -- allows doctors to study how well a tumor responds to a cancer regimen. If the therapy is successful, there are no cancer cells remaining at the time of surgery--and the patient is said to have had a "pathologic complete response." Some studies have suggested that women who have a pathologic complete response after neoadjuvant treatment have a better prognosis. Fulvestrant (Faslodex®) is a hormone therapy used to treat ER+ metastatic breast cancer in postmenopausal women who have tried other hormone therapies. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat breast cancer. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2 targeted therapies. This study will look at the effectiveness of using Faslodex, Taxotere, Herceptin and Perjeta to obtain a pathologic complete response in women with ER+, HER2+ breast cancer.

Ruxolitinib And Taxol in Advanced Triple Negative, Inflammatory Breast Cancer

Phase II Study of Combination Ruxolitinib (INCB018242) With Preoperative Chemotherapy for Triple Negative Inflammatory Breast Cancer Following Completion of a Phase I Combination Study in Recurrent/Metastatic Breast Cancer (NCT02041429)

Summary

Ruxolitinib was approved by the FDA in 2011 to treat a type of bone marrow cancer. Laboratory studies have shown that the drug blocks a pathway (called IL6/JAK/Stat), which may stop cancer cells from growing. Paclitaxel (Taxol®) is a chemotherapy drug that is routinely used to treat breast cancer patients. Laboratory experiments suggest that giving ruxolitinib along with Taxol may make the Taxol more effective. This study is investigating the safety and effectiveness of giving ruxolitinib and Taxol to women with advanced or metastatic triple-negative, inflammatory breast cancer for which there are no other standard treatments available. It is the first study to test this drug combination in breast cancer.
This is a Phase I-II trial

Palbociclib and an Aromatase Inhibitor for Stage II-III ER+, HER2- Breast Cancer

A Phase 2 Pilot Feasibility Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive Invasive Breast Cancer (NCT02040857)

Summary

Palbociclib (PD-0332991) is a new type of targeted therapy called a CDK inhibitor. It blocks two enzymes, called CDK 4 and 6, that are part of a pathway that regulates cell growth. Laboratory studies suggest that palbociclib may be effective against hormone sensitive breast cancer. Aromatase inhibitors (AIs) are routinely used to treat post-menopausal women with hormone-sensitive breast cancer. The AIs currently used are letrozole (Femara®), anastrazole (Arimidex®), and exemestane (Aromasin®). This study is looking at the effectiveness of combining palbociclib with an AI in postmenopausal women with stage II or stage III breast cancer. To be eligible, participants must have been on an AI for at least 3 months without experiencing side effects that would prohibit them from taking an AI for at least two years. Patients may enroll at any point within two years of starting on an AI, as long as they plan to be on an AI for at least two more years.
This is a Phase II trial

Reducing the Risk of Breast Cancer in Women with DCIS

Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor (NCT01372618)

Summary

Women who have been diagnosed with ductal carcinoma in situ (DCIS) are at increased risk of developing invasive breast cancer. Studies have shown that tamoxifen can reduce the risk of invasive breast cancer in women who have been diagnosed with DCIS, but it also has potential side effects. Researchers are trying to develop new drugs for preventing breast cancer that will be as or more effective than tamoxifen and have fewer side effects. IGF-1 is a hormone that is a part of a cell signaling pathway that controls cell growth. Pasireotide (SOM230) is an experimental drug that works by blocking the IGF-1 pathway. This trial is studying the effects that pasireotide has on DCIS. To be eligible, participants must not have taken tamoxifen or other preventive measures within 6 months.
This is a Phase I trial

Everolimus, Herceptin & Vinorelbine for HER2+ Brain Metastases

A Phase II Study Evaluating The Efficacy And Tolerability Of Everolimus (RAD001) In Combination With Trastuzumab And Vinorelbine In The Treatment Of Progressive HER2-Positive Breast Cancer Brain Metastases (NCT01305941)

Summary

Breast cancer that has metastasized (spread) to the brain is difficult to treat because most chemotherapy drugs are unable to cross the blood-brain barrier into the brain. Scientists are trying to develop new therapies that will overcome this problem. Everolimus (Afinitor®) is a type of drug called an mTOR inhibitor. It works by interfering with the mTOR (mammalian target of rapamycin) protein, which is responsible for cell growth. Studies have shown that everolimus can cross the blood-brain barrier. Vinorelbine (Navelbine®) and trastuzumab (Herceptin®) are two drugs that are commonly used to treat metastatic HER2+ breast cancer. This trial will evaluate the effectiveness, safety, and tolerability of a treatment regimen that combines everolimus with vinorelbine and Herceptin in patients with HER2-positive breast cancer brain metastases.
This is a Phase II trial

Afinitor and Hormone Therapy for Advanced Breast Cancer

Phase II Study of Everolimus Beyond Progression in Postmenopausal Women With Advanced, Hormone Receptor Positive Breast Cancer (NCT02269670)

Summary

Everolimus (Afinitor®) is a new type of targeted therapy called an mTOR inhibitor. It is used along with the hormone therapy exemstane (Aromasin) to treat postmenopausal women with advanced hormone-sensitive, HER2-negative tumors. Researchers think giving Afinitor with a different type of hormone therapy may be an effective way to treat patients whose tumors have progressed or recurred following treatment with Afinitor and Aromasin. This study will evaluate the safety and effectiveness of Afinitor and a hormone therapy, to be selected by the physician, in patients with hormone-sensitive, HER2-negative breast cancer who have already tried Afinitor and Aromasin.
This is a Phase II trial

Chemotherapy, Herceptin, Plus Tykerb for HER2-Positive Metastatic Cancer

Phase II Trial of Metronomic Capecitabine and Cyclophosphamide With Lapatinib and Ttrastuzumab in Patients With HER2 Positive Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen (NCT01873833)

Summary

Researchers are looking for new combination of drugs to treat HER2+ metastatic breast cancer. Cyclophosphamide (Cytoxan®) is a chemotherapy drug that stops the growth of tumor cells. Lapatinib (Tykerb®) is a targeted therapy commonly used with Capacitabine (Xeloda®) to treat HER2+ metastatic breast cancer. Trastuzumab (Herceptin®) is routinely used to treat HER2+ breast cancer. Combining these drugs may be a more effective regimen for treating HER2+ metastatic breast cancer.
This is a Phase II trial

MGAH22 for Metastatic Breast Cancer with a 2+ HER2 Status

A Phase I Clinical Trial of mTOR Inhibition With Rapamycin for Enhancing Intranodal Dendritic Cell Vaccine Induced Anti-Tumor Immunity In Patients With NY-ESO-1 Expressing Solid Tumors (NCT01828021)

Summary

Breast cancer tumors are tested to determine their HER2 status. Two tests are used: IHC and FISH. A tumor that scores 3+ on IHC or positive on the FISH test is most likely to respond to a HER2-targeted therapy. MGAH22 (margetuximab) is a new targeted therapy that researchers believe may be effective in patients whose tumors score less than 3+ on IHC or negative on the FISH test. The goal of this study is to see how metastatic tumors that score 2+ on an IHC test respond to MGAH22.
This is a Phase II trial

Orteronel For Androgen Receptor-Positive Metastatic Breast Cancer

A Phase II Study With Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR) (NCT01990209)

Summary

Orteronel (TAK-700) is a new type of cancer drug that works by blocking the androgen receptor (AR). It is currently in phase III trials for prostate cancer. Studies have found that about 70-90 percent of primary breast tumors and 75 percent of breast metastases are AR+. Researchers believe orteronel may be an effective treatment for metastatic breast cancer patients whose tumors are AR+. This study is investigating the effectiveness of orteronel in patients with triple negative or ER+ and/or PR+ metastatic breast cancer that is AR+. The researchers will test tumor tissue from a previous biopsy to determine if a patient's tumor is AR+.
This is a Phase II trial

MK-3475 and INCB024360 in Breast Cancer (And Other Solid Tumors)

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of MK-3475 in Combination With INCB024360 in Subjects With Selected Solid Tumors (Phase 1) Followed by a Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Advanced NSCLC (Phase 2) (NCT02178722)

Summary

Researchers are developing new drugs to treat breast cancer and other types of solid tumors. INCB024360 is a new drug that works by blocking an enzyme called IDO1, which suppresses the immune system. Laboratory studies have shown that INCB024360 can activate the immune system and inhibit the growth of cancer cells that express IDO1. MK-3475 (pembrolizumab) is an experimental drug that disables PD-1, a protein that prevents the immune system from attacking tumor cells. Studies suggest that MK-3475 may be an effective treatment for triple negative breast cancer. This study is comparing the safety and effectiveness of the combination of MK-3475 and INCB024360 to MK-3475 and a placebo in patients with advanced breast cancer. This study is also enrolling patients with other types of solid tumors.
This is a Phase I-II trial

Arimidex® & Targeted Therapy for Advanced Breast Cancer

Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance (NCT01197170)

Summary

Researchers are studying new drug combinations that can be used to treat advanced breast cancer. The goal of this study is to identify the highest tolerated dose of the aromatase inhibitor anastrozole (Arimidex®) when it is given alone or in combination with everolimus (Afinitor®), sorafenib (Nexavar®), erlotinib (Tarceva®), fulvestrant (Faslodex®), or bevacizumab (Avastin®), all of which can be used to treat advanced breast cancer. During the course of the study, if a patient develops resistance to the two drug combination, a third drug will be added to the treatment regimen. To be eligible, participants must have advanced or metastatic cancer that has not responded to standard therapy.
This is a Phase I trial

Comparing PF-05280014 to Herceptin® In HER2+ First Line Metastatic Breast Cancer

A Phase 3 Randomized, Double-Blind Study Of PF-05280014 Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel For The First-Line Treatment Of Patients With HER2-Positive Metastatic Breast Cancer (NCT01989676)

Summary

PF-05280014 is a new drug that researchers believe is equivalent to the trastuzumab (Herceptin) used in Europe. Paclitaxel (Taxol) is a chemotherapy drug routinely used to treat breast cancer. This study is comparing the safety, pharmacokinetics and effectiveness of PF-05280014 and Taxol to Herceptin and Taxol in women with HER2-positive metastatic breast cancer who have not yet received HER2-targeted therapy. To be eligible, participants must have relapsed within one year of their last dose of adjuvant or neoadjuvant treatment.
This is a Phase III trial

Halaven, Herceptin and Perjeta for Advanced HER2-Positive Breast Cancer

A Phase II Study of Eribulin Mesylate in Combination With Trastuzumab and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer (NCT01912963)

Summary

Researchers are trying to identify the most effective drug combinations for treating advanced HER2+ breast cancer. Eribulin (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer. Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are targeted therapies used to treat HER2-positive tumors. These three drugs have not yet been tested as a combination therapy. This study is looking at the safety and effectiveness of using Halaven, Herceptin and Perjeta to treat advanced HER2-positive breast cancer.
This is a Phase II trial

Comparing Kadcyla & Perjeta to Herceptin, Perjeta & a Taxane for HER2+ Breast Cancer

A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III TRIAL COMPARING TRASTUZUMAB PLUS PERTUZUMAB PLUS A TAXANE FOLLOWING ANTHRACYCLINES VERSUS TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB FOLLOWING ANTHRACYCLINES AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2?POSITIVE PRIMARY BREAST CANCER (NCT01966471)

Summary

Researchers want to determine the most effective drug combination for treating early-stage HER2+ breast cancer. Trastuzumab (Herceptin®) is a HER2-targeted therapy used to treat early-stage and metastatic breast cancer. Trastuzumab emtansine (T-DM1/Kadcyla®) combines the chemotherapy drug DM1 with Herceptin. It currently is used to treat metastatic HER2+ breast cancer. Pertuzumab (Perjeta®) is a HER2-targeted therapy used to treat metastatic HER2+ breast cancer. It attaches to a different part of the HER2 receptor than Herceptin. Taxanes are a type of chemotherapy drug used to breast cancer. This study is looking at whether it is safer and more effective to give Kadcyla and Perjeta or Herceptin, Perjeta and a taxane to patients with HER2-positive stage I-III breast cancer.
This is a Phase III trial

Dose Adjustments to Reduce Afinitor-Induced Mouth Sores

Phase II Evaluation of Real-Time, Pharmacokinetically Guided Everolimus in Patients With Hormone Receptor Positive Breast Cancer, Pancreatic Neuroendocrine Tumors (PNET), and Renal Cell Carcinoma (NCT02273752)

Summary

Everolimus (Afinitor®) is a new type of targeted therapy called an mTOR inhibitor. Mouth sores (stomatitis)) are a common side effect of Afinitor. In this study, postmenopausal women with ER+, HER2- breast cancer (and other solid tumors) taking Afinitor will have their blood analyzed weekly. The researchers will use that information to adjust the dose of Afinitor when necessary to reduce mouth sores while maintaining the drug's effectiveness. To be eligible, participants must have already been treated with letrozole (Femara®) or anastrozole (Arimidex®).
This is a Phase II trial

IGF-Methotrexate Conjugate For Advanced Tumors Expressing IGF-1R

STM-02: Phase I Study of IGF-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing IGF-1R (NCT02045368)

Summary

Studies have shown that the insulin-like growth factor 1 receptor (IGF-1R) is overexpressed in a number of different types of cancers, including breast cancer. IGF-methotrexate conjugate (765IGF-MTX) is a targeted therapy that delivers the chemotherapy drug methotrexate by attaching it to insulin-like growth factor (IGF). Laboratory studies have shown that IGF-methotrexate conjugate is more effective at killing cancer cells than methotrexate. This study is designed to establish the side effects and best dose of IGF-methotrexate conjugate in patients with advanced tumors that have stopped responding to standard therapy. Patients interested in this trial will have their tumors tested for IGF-1R. Those who have a tumor that tests positive for IGF-1R will be eligible for the study.
This is a Phase I trial

Olaparib with AZD2014 or AZD5363 for Recurrent Triple Negative Breast Cancer

A Phase Ib Study of the Oral PARP Inhibitor Olaparib With the Oral mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial, Triple Negative Breast, and Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT02208375)

Summary

Researchers are developing new types of cancer treatments. Olaparib is a new type of cancer drug called a PARP-inhibitor. It interferes with the cancer cell's DNA, making it more sensitive to chemotherapy. AZD2014 is a new type of targeted therapy called an mTOR1/2 inhibitor. AZD5363 is a new type of targeted therapy called an AKT protein kinase inhibitor. This study is investigating the best dose and combination of olaparib, AZD2014 and AZD5363 to use in treating patients with recurrent triple negative (ER-, PR-, HER2-) breast cancer. This study also is enrolling patients with endometrial, ovarian, primary peritoneal or fallopian tube cancers.)
This is a Phase I-II trial

GDC-0032 & Femara Before Surgery for Postmenopausal Women With ER+, HER2- Tumors

A Phase II Randomized, Double-Blind, Parallel Cohort Study of Neoadjuvant Letrozole + GDC-0032 Versus Letrozole + Placebo in Post-Menopausal Women With ER+/HER2- Primary Breast Cancer (NCT02273973)

Summary

Researchers are developing new types of targeted therapies. Giving these therapies before surgery--called neoadjuvant treatment--allows researchers to study the effect that the therapy has on the breast tumor. GDC-0032 is a new type of drug called a PI3K inhibitor. It works by blocking the PI3K pathway, which plays a role in tumor cell growth. Letrozole (Femara®) is a type of anti-estrogen treatment called an aromatase inhibitor. It is used to treat postmenopausal women with hormone-sensitive breast cancer. This study is comparing the effect of Femara and GDC-0032 to Femara and a placebo when it is given before surgery to postmenopausal women with ER-positive, HER2-negative breast cancer.
This is a Phase II trial

Istodax and Abraxane For Metastatic Inflammatory Breast Cancer

A Phase I/II Study of Romidepsin in Combination With Abraxane in Patients With Metastatic Inflammatory Breast Cancer (NCT01938833)

Summary

Researchers are studying new treatments for inflammatory breast cancer (IBC). Romidepsin (Istodax®) is a histone deacetylase (HDAC) inhibitor. It works by entering cancer cells and blocking the activity of proteins, called histone deacetylases, that help cancer cells grow. Laboratory studies suggest that Istodax, which is used to treat lymphoma, may be an effective treatment for IBC. Protein-bound paclitaxel (Abraxane®) is a chemotherapy drug used to treat IBC. Giving Istodax wtih Abraxane may be more effective than giving Abraxane alone. This study is designed to determine the side effects and best dose of Istodax to use with Abraxane to treat women with metastatic IBC.
This is a Phase I-II trial

A New PARP Inhibitor For BRCA-Positive Advanced Breast Cancer

Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations (NCT01989546)

Summary

BMN 673 is a new type of cancer drug called a PARP inhibitor. It works by blocking the PARP —poly (ADP-ribose) polymerase—protein that helps cells repair DNA damage. Early studies suggest BMN 673 may be effective in patients with advanced breast cancer who have a BRCA mutation. This study is evaluating the effect that BMN673 has on cancer cells (through tumor biopsies) of patients with advanced breast cancer who have a known BRCA inherited mutation.
This is a Phase I-II trial

PM01183 and Taxol for Advanced Breast (and Selected Other) Cancers

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Weekly Paclitaxel, With or Without Bevacizumab, in Patients With Selected Advanced Solid Tumors (NCT01831089)

Summary

Researchers are studying new types of targeted therapies that may be effective in breast cancer (and other types of solid tumors). Lurbinectedin (PM01183) is a synthetic drug that mimics a natural occurring molecule that can block tumor cell growth by binding to specific locations on DNA. Paclitaxel (Taxol®) is a chemotherapy drug that is used routinely to treat breast cancer. This study is looking at the safety, efficacy, and best dose of PM01183 when it is given with Taxol to individuals with advanced breast cancer.
This is a Phase I trial

Dovitinib & Fulvestrant for HER2- & ER or PR+ Advanced Disease

A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have... (NCT01528345)

Summary

Researchers are trying to identify new targets for cancer therapies. Dovitinib is an investigational drug called a fibroblast growth factor receptor 1 (FGFR1) inhibitor. It works by attaching to and keeping the FGFR1 protein from receiving growth signals. Studies have found that about 8% to 10% of breast cancers are FGFR1-positive. (Tumors are currently not tested for their FGFR status.) Fulvestrant (Faslodex®) is an estrogen receptor down-regulator that is used to treat patients whose tumors have advanced on anti-estrogen therapies. It works by blocking the action of estrogen on cancer cells. This trial is enrolling postmenopausal patients with locally advanced or metastatic HER2-negative and ER-positive and/or PR-positive breast cancer that cannot be cured by surgery or radiation, and whose disease has progressed on or after prior endocrine therapy, to study the effectiveness of combining Faslodex with dovitinib.
This is a Phase II trial

AZD5363 and Dabrafenib for ER+, HER2+ Advanced Breast Cancer

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 +Dabrafenib Under Adaptable Dosing Schedules in Patients With Advanced Solid Tumors That Are Metastatic or Cannot be Removed by Surgery (NCT02212743)

Summary

AZD5363 is an AKT inhibitor, a new type of targeted therapy. It works by blocking the AKT1 protein, which plays a role in cancer cell growth. Dabrafenib (Tafinlar®) is a targeted therapy that is used to treat certain types of metastatic melanoma. It works by inhibiting a protein called BRAF, which helps tumors grow. This study will determine the safety and effectiveness of giving AZD5363 and Tafinlar to patients with ER+, HER2+ breast cancer that has spread to other parts of the body (metastasized) or cannot be surgically removed. All patients who are interested in the trial will have their tumor tested for BRAF, AKT1 and PIK3CA gene mutations. Only patients whose tumors have at least one of these mutations will be eligible for the study. (This study also is enrolling patients with other types of cancers.)
This is a Phase I-II trial

Using PET to Study How ER-, HER2+ Tumors Respond to HER2 Therapies Given Before Surgery

A Phase 2 Clinical Trial Assessing the Correlation of Early Changes in Standardized Uptake Value (SUV) on Positron Emission Tomography (PET) With Pathological Complete Response (pCR) to Pertuzumab and Trastuzumab in Patients With Primary Operable HER2-Positive Breast Cancer (NCT01937117)

Summary

Patients with ER-negative, HER2-positive tumors are typically treated with chemotherapy and a HER2-targeted therapy. Researchers are trying to determine if there are ER-, HER2+ patients who could be treated with HER2-targeted therapies alone. Giving a targeted therapy before surgery (called neoadjuvant treatment) allows researchers to study how the tumor responds to the therapy. PET (Positron Emission Tomography) is an imaging technology that allows researchers to monitor changes in the breast tumor. Trastuzumab (Herceptin®) and Pertuzumab (Perjeta®) are two of the HER2-targeted therapies used to treat HER2+ breast cancer. This study is looking at the effectiveness of using PET scans to measure tumor response in patients with ER-, HER2+ breast cancer who receive Herceptin and Perjeta before surgery.
This is a Phase II trial

Femara With or Without Afatinib in Postmenopausal Women with Advanced ER+, HER2- Tumors

A Randomized Open-label Phase II Study of Letrozole Plus Afatinib (BIBW2992) Versus Letrozole Alone in First Line Treatment of Advanced ER+, HER2- Post-menopausal Breast Cancer With Low ER Expression (NCT02115048)

Summary

Researchers are studying news treatments for advanced breast cancer. Letrozole (Femara®) is an aromatase inhibitor that is commonly used to treat hormone-sensitive breast cancer in postmenopausal women. Afatinib (Gilotri®) is a targeted therapy that is designed to slow cancer cell growth by blocking the EGFR receptor and the HER2 receptor. It is currently used to treat metastatic EFGR+ non-small cell lung cancer. Findings from earlier studies suggest Gilotri may also be effective against breast cancer. This study is comparing the safety and effectiveness of Femara and Gilotri to Femara alone as a first-line treatment in postmenopausal women with ER+, HER2- advanced breast cancer. All patients interested in this study will have their tumor's ER expression measured. Only those women who have tumors with low ER expression will be eligible.
This is a Phase II trial

Local Treatment for For Skin & Chest Wall Metastases

Phase I/II Study of TLR7 Agonist Imiquimod and Radiotherapy in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases (NCT01421017)

Summary

Breast cancer is the second-most likely cancer to result in skin metastases. More effective and less toxic local treatments are needed to treat these metastases. Imiquimod (Aldara®) is a topical cream that is currently used to treat certain precancerous and cancerous skin growths. It works by stimulating the immune system and promoting tumor cell death. The purpose of this study is to determine the best dose and effectiveness of imiquimod when it is combined with radiation therapy for women with skin or chest wall metastases. To be eligible, participants must have skin or chest wall metastases as well as metastases at another distant site.
This is a Phase I-II trial

Temsirolimus and Metformin For Advanced Breast Cancer

Phase I Study of Temsirolimus in Combination With Metformin in Patients With Advanced Cancers (NCT01529593)

Summary

Researchers are looking for new ways to stop the growth of cancer cells. Temsirolimus (Torisel®) blocks a protein called mTOR that plays a role in cancer cell growth. It is used to treat advanced kidney cancer. Metformin is used to control blood sugar in patients with Type 2 diabetes. Studies suggest it may also have anti-cancer properties. The goal of this study is to identify the safety and highest dose of the combination of temsirolimus and metformin that can be given to patients with advanced breast cancer. (This study is also enrolling patients with other types of advanced cancer.)
This is a Phase I trial

Sorafenib and Capecitabine (Xeloda®) For Advanced Breast Cancer

Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors (NCT01640665)

Summary

Combining two drugs that work in two different ways to treat metastatic breast cancer may be more effective than using one drug alone. Sorafenib (Nexavar®) is approved for the treatment of advanced kidney and other cancers. Like bevacizumab (Avastin®), Nexavar is an anti-angiogenesis agent that works by blocking the growth of the new blood vessels a tumor needs to grow and thrive. However, it exerts its effects via a different mechanism of action that involves more cellular pathways. The purpose of this study is to find the maximum tolerated dose of Nexavar that should be used in combination with Xeloda.
This is a Phase I trial

Cobimetinib and Paclitaxel for Advanced Triple Negative Breast Cancer

A Study of Cobimetinib in Combination With Paclitaxel as First-line Treatment for Patients With Metastatic Triple-negative Breast Cancer (NCT02322814)

Summary

Researchers are looking for new drug combinations to treat advanced triple-negative breast cancer. Cobimetinib (CDG-0973) is a new targeted therapy researchers are studying that works by inhibiting a protein called MEK that helps cancer cells grow and survive. Paclitaxel (Taxol®) is a chemotherapy drug that is commonly used to treat advanced breast cancer. This study is comparing the safety and effectiveness of Taxol and cobimetinib in comparison with Taxol and a placebo as a first-line treatment in patients with advanced triple negative breast cancer.
This is a Phase II trial

Fulvestrant & Ganetespib for Hormone-Sensitive Advanced Disease

Randomized Phase II Study of Fulvestrant With or Without Ganetespib in Patients With Hormone Receptor-Positive, Metastatic Breast Cancer (NCT01560416)

Summary

Over time, tumors often become resistant to the drugs being used to treat them. The investigational drug ganetespib (STA-9090) is an HSP90 inhibitor. It works by blocking HSP90 (heat shock protein 90), a molecular chaperone that plays a role in cell signaling. This reduces the ability of cancer cells to become resistant to treatment. Fulvestrant (Faslodex®) is used to treat metastatic, estrogen-sensitive tumors. It works by keeping estrogen from getting into the cancer cells; it also decreases the number of estrogen receptors on the cancer cells. In the laboratory, adding ganetespib to fulvestrant appears to improve its effectiveness. It is not yet known whether this is true in humans. This research study is evaluating the effect of adding ganetespib to fulvestrant for the treatment of hormone-sensitive metastatic breast cancer.
This is a Phase II trial

LGK974 for Metastatic Lobular Breast Cancer

A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Melanoma and Lobular Breast Cancer (NCT01351103)

Summary

Researchers are looking for new ways to treat metastatic lobular breast cancer. The Wnt pathway is a network of proteins that may play a role in how cancer develops. LGK974 is an experimental drug that is designed to inhibit he Wnt pathway. The goal of this study is to determine the safety, best dose, and effectiveness of LGK974 when it is given to individuals with metastatic lobular breast cancer for whom there are no standard treatment options.
This is a Phase I trial

Aromasin® and Entinostat For ER+, HER2-, Advanced Breast Cancer

A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Postmenopausal Patients With Hormone Receptor-Positive Advanced Breast Cancer (NCT02115282)

Summary

Exemestane (Aromasin®) is a type of hormone therapy that is routinely used to treat postmenopausal women with hormone-sensitive breast cancer. Entinostat is a new type of drug called a histone deacetylase (HDAC) inhibitor. It works by blocking HDAC enzymes, which are needed for cell growth. In this study, researchers are investigating whether using Aromasin and entinostat together is more effective than using Aromasin alone to treat men and postmenopausal women with hormone-sensitive, HER2-negative advanced breast cancer.
This is a Phase III trial

Ipatasertib and Taxol Before Surgery for Early-Stage Triple-Negative Breast Cancer

A PHASE II RANDOMIZED, DOUBLE-BLIND, STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR TO AKT, IN COMBINATION WITH PACLITAXEL AS NEOADJUVANT TREATMENT FOR PATIENTS WITH EARLY STAGE TRIPLE NEGATIVE BREAST CANCER (NCT02301988)

Summary

Scientists are trying to develop new drugs that will be effective for patients with triple-negative breast cancer. Giving treatment before surgery, called neoadjuvant therapy, allows researchers to study the effect that the treatment has on cancer cells. Ipatasertib (GDC-0068) is a new type of targeted cancer therapy called an AKt inhibitor. It blocks a pathway inside the cell that regulates the cell's growth and survival. Early studies suggest that ipatasertib may be effective in patients with triple-negative breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug that is used to treat breast cancer. This study is comparing the effectiveness of Taxol and ipatasertib to Taxol and a placebo when it is given before surgery to patients with early-stage triple-negative breast cancer.
This is a Phase II trial

Trametinib + GSK2141795 for Metastatic Triple-Negative Breast Cancer

A Single Arm, Phase II Study of Single Agent Trametinib Followed by Trametinib in Combination With GSK2141795 in Patients With Advanced Triple Negative Breast Cancer (NCT01964924)

Summary

Researchers are studying new drug treatments for triple negative metastatic breast cancer. Trametinib (Mekinist™) is approved to treat certain types of metastatic melanoma. Its use in breast cancer is considered experimental. GSK2141795 is a new type of drug called an Akt inhibitor. Blocking Akt can help lead to cell death. Studies suggest that using both drugs together may be an effective way to treat triple-negative breast cancer. This study is investigating the safety and effectiveness of trametinib alone and then, after progression, with GSK2141795 in patients with metastatic triple negative breast cancer who have had at least one but no more than three prior chemotherapy regimens.
This is a Phase II trial

Tykerb & Radiation to Treat Locally Advanced or Recurrent Breast Cancer

Phase II Study to Investigate Concurrent Lapatinib and Radiotherapy in Locally Advanced or Locally Recurrent Breast Cancer and the Impact on Breast Cancer Stem Cells (NCT01868503)

Summary

Researchers are studying new options for treating locally advanced or locally recurrent breast cancer. Lapatinib ditosylate (Tykerb®) is currently used in combination with capecitabine (Xeloda®) to treat advanced HER2+ breast cancer. Radiation therapy is routinely used to treat breast cancer. The goal of this study is to look at the safety and effectiveness of using Tykerb and radiation therapy together to treat locally advanced or locally recurrent breast cancer.
This is a Phase II trial

ALK Inhibitor X-396 For Advanced Breast Cancer

Phase 1, First-in-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of X-396 in Patients With Advanced Solid Tumors (NCT01625234)

Summary

Researchers are developing new types of cancer therapies. ALK is a protein that is involved in cancer cell growth and survival. X-396 is an investigational drug that targets the ALK protein. Laboratory studies suggest it may be effective against advanced cancers. This study is designed to identify highest dose of X-396 that can be safely used. This study is testing X-396 in patients with breast cancer as well as other types of solid tumors. To be eligible, participants must test positive for the ALK protein.
This is a Phase I trial

Herceptin in Women Over 65 With Early-Stage Breast Cancer

Safety and Efficacy of Single Agent Adjuvant Trastuzumab in Older Women With Early Stage Breast Cancer: A Phase II Trial (NCT00796978)

Summary

The drug trastuzumab (Herceptin®) is used to treat early-stage and advanced breast cancer that is HER2-positive. Women who are on this drug have regular tests to monitor their heart function, because one of the drug's known side effects is heart damage. This study is investigating the safety and effectiveness of Herceptin in women 65 and older who have HER2-positive early-stage breast cancer. Participants must have had surgery and radiation and be unable or unwilling to receive chemotherapy.
This is a Phase II trial

LY2606368 For Metastatic Triple Negative or BRCA1/2-Associated Breast Cancer

A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in Women With BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Non-High Risk Triple Negative Breast Cancer, and High Grade Serous Ovarian Cancer at Low Genetic Risk. (NCT02203513)

Summary

LY2606368 is a new type of cancer drug called a Chk1/2 (checkpoint kinases 1/2) inhibitor. By blocking the activity of Chk1/2, LY2606368 may slow or stop cancer cell growth. Early studies suggest LY2606368 may be an effective treatment for certain types of breast tumors. This study is looking at whether LY2606368 can shrink tumors in patients with metastatic breast cancer who carry a BRCA1/2 mutation or who have a triple-negative (ER-, PR-, HER2-) tumor. To be eligible for this study, patients must have already tried standard treatments.
This is a Phase II trial

Vandetanib Before Surgery to Study Its Effect on Cancer Cells in Stage I-III Breast Tumors

A Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Effect of Vandetanib on Cellular Markers of Proliferation and Apoptosis in Invasive Breast Cancer (NCT01934335)

Summary

Giving treatment before surgery (called neoadjuvant therapy) allows researchers to study the effect that the treatment has on cancer cells. Vandetanib (Caprelsa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It is approved for treating thyroid cancer. Ki-67 is a protein in cells that increases as the cell prepares to divide into new cells. By measuring Ki67, researchers can learn how quickly the cancer calls are growing. This study is comparing the effect of Caprelsa and a placebo on Ki-67 (and other markers of tumor growth) when it is given before surgery to patients with stage I, II or III breast cancer. To be eligible, a patient must have had a core biopsy showing an invasive tumor and be scheduled to have surgery.

Pazopanib to Reverse Resistance to Hormone Therapy

Reversing Hormone Resistance in Advanced Breast Cancer With Pazopanib (NCT01466972)

Summary

Anti-estrogen therapies are used to treat breast tumors that are hormone sensitive. Over time, some tumors will stop responding to these treatments. Researchers are looking for ways to get a breast tumor that has stopped responding to hormone therapy to start responding again to this treatment. The tyrosine kinase inhibitor pazopanib (Votrient®) is currently used to treat kidney cancer. It works by interfering with cell communication and growth. Studies suggest it may also be able to get hormone-sensitive tumors to begin responding again to anti-estrogen therapies. The goal of this trial is to investigate the effectiveness of giving pazopanib to individuals whose cancer has progressed while on letrozole (Femara®) or anastrozole (Arimidex®).
This is a Phase II trial

Chemotherapy, Herceptin, Perjeta & an AI Before Surgery for ER+, HER2+ Stage I-III Tumors

A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients With Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated With Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation (NCT02003209)

Summary

Researchers are trying to determine the best treatment for ER+, HER2+ tumors. Docetaxel (Taxotere®) and carboplatin (Paraplatin®) are two types of chemotherapy drugs used to treat breast cancer. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2+ tumors. This four drug combination is called TCHP. Aromatase inhibitors (AIs) are used to treat ER+ tumors in postmenopausal women. Premenopausal women can use an AI if they also take Goserelin (Zoladex®), a drug that stops ovarian function. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study the effect that a treatment has on cancer cells. This study is comparing the effect of giving TCHP with an AI to giving TCHP alone before surgery to women with stage I-III breast cancer. Following treatment, all of the women will have a lumpectomy or mastectomy followed by whole breast radiation and one year of Herceptin.
This is a Phase III trial

Response of Triple Negative Breast Cancer to Trametinib

Defining the Triple Negative Breast Cancer Kinome Response to GSK1120212 (NCT01467310)

Summary

Research are trying to develop cancer therapies that work by blocking the activity of cancer-promoting proteins called kinases. The experimental drug trametinib (GSK1120212) works by blocking a kinase called MEK. In this study, the researchers will give volunteers trametinib for a short period of time so that they can evaluate how MEK and the other kinases act before and after trametinib is given. This study is not intended to treat cancer; it is looking at ways that the investigators may treat cancer in the future. To be eligible, participants must have stage I-III triple negative (ER-/PR-/HER2-) breast cancer, have not yet had surgery, and not be planning to receive any treatment before surgery.

Jevtana® and Tykerb® for HER2-Positive Brain Metastases

Phase II Study With Lead-in Safety Cohort of Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases (NCT01934894)

Summary

To treat brain metastases, drugs needs to be able to cross the blood-brain barrier. Lapatinib (Tykerb®) is a targeted therapy used to treat HER2+ advanced breast cancer. Cabazitaxel (Jevtana®) is a new type of taxane that studies suggest can cross the blood-brain barrier. It is currently used to treat advanced prostate cancer that has stopped responding to other treatments. This study is investigating the safety and effectiveness of using Tykerb and Jevtana to treat HER2-positive breast cancer that has spread to the brain.
This is a Phase II trial

Vorinostat for HIV+ Patients with Advanced Breast Cancer

Vorinostat in Combination With Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection (NCT01249443)

Summary

Researchers are studying new drugs and new drug combinations for HIV-positive women with advanced breast cancer. Vorinostat (Zolinza®) is a type of medication called a histone deacetylase (HDAC) inhibitor. It works by blocking HDAC enzymes, which are needed for cell growth. Vorinostat is currently used to treat a type of lymphoma. Clinical and laboratory research suggests that vorinostat may also be effective against AIDS and cancers other than lymphoma. The chemotherapy drugs paclitaxel (Taxol®) and carboplatin (Paraplatin®) work in different ways to slow or stop tumor growth. The goal of this trial is to determine the best dose and side effects of vorinostat when given together with Taxol and carboplatin to HIV+ patients with advanced breast cancer.
This is a Phase I trial