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Targeted therapy - Early stage

A targeted therapy for breast cancer attacks specific molecules in cancer cells. Researchers are developing targeted therapies for early stage breast cancer to reduce the risk of a cancer recurrence.

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

Vectibix, Paraplatin & Taxol Before Surgery For Early Stage Triple Negative Disease

Women's Triple-Negative First-Line Study: A Phase II Trial of Panitumumab, Carboplatin and Paclitaxel (PaCT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NCT02593175)

Summary

To take part in this study, you must have been diagnosed with triple-negative, early-stage breast cancer but not yet had surgery. In addition, you must have a type of tumor that is not likely to get smaller if you receive the standard type of chemotherapy given before surgery. Vectibix, Paraplatin, and Taxol are three different types of cancer drugs. Researchers think that giving all three drugs at the same time before surgery will shrink triple negative tumors. Panitumumab (Vectibix®) is a targeted treatment used to treat certain types of colorectal cancer. Its use in breast cancer is considered experimental. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs that are used to treat breast cancer.
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

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

Doxil, Avastin and Torisel Before Surgery for Triple-Negative Breast Cancer

Women's Triple-Negative First-Line Study: A Phase II Trial of Liposomal Doxorubicin, Bevacizumab and Temsirolimus (DAT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NCT02456857)

Summary

In this study, participants will receive the experimental drug regimen DAT, which consists of liposomal doxorubicin (Doxil®), bevacizumab (Avastin®), and temsirolimus (Torisel®). Doxil is a chemotherapy drug used to treat breast cancer. Avastin works by keeping the cancer from making the blood vessels it needs to grow. It currently is not approved as a breast cancer treatment. Torisel is an mTOR inhibitor. It works by blocking a protein called mTOR that helps cancer cells grow. Treatment given before surgery--called neoadjuvant therapy---allows researchers to see the effect that the treatment has on the tumor. This study is investigating the effect that the DAT regimen has when it is given before surgery to women with triple-negative breast cancer. To be eligible, patients must have stopped a neoadjuvant anthracycline-based regimen because the cancer progressed or they experienced too many side effects to continue.
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

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.

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

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

Hormone Therapy With or Without Ibrance for HR+, HER2- Stage II-III Breast Cancer

PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer (PALLAS) (NCT02513394)

Summary

Palbociclib (Ibrance®) was approved in February 2015 for treating metastatic breast cancer. Now, researchers want to determine if it will be an effective treatment for early-stage breast cancer. This study, called PALLAS, is investigating whether using Ibrance along with an endocrine therapy after surgery is more effective than hormone therapy alone for reducing recurrence in patients with hormone-sensitive, HER2-negative stage II or stage III breast cancer. To be eligible, participants must be planning to start hormone therapy or have already started hormone therapy (within the last 6 months).
This is a Phase III 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

Effect of Xgeva on Breast Tissue in Women Treated for DCIS, Stage I-III Breast Cancer

Phase II Correlative Study of Denosumab Effects on Tissue and Imaging Breast Biomarkers (NCT02613416)

Summary

Researchers are studying the relationship between breast density and breast cancer. Laboratory studies suggest a protein called the RANK ligand may be linked to breast density. Denosumab (Xgeva®) is an anti-RANK antibody that inhibits the RANK protein. In patients with bone metastases, Xgeva is used to prevent fractures, spinal cord compression, or the need for bone radiation or surgery. This study will investigate the effect that Xgeva has on breast tissue in women who have completed treatment for DCIS or stage I, II or III breast cancer. This study is being conducted at the Stony Brook University Cancer Center in New York. For more information, call: 631-638-0852.
This is a Phase II 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

Femara, Afinitor and TRC105 Before Surgery for HR+ & HER2- Postmenopausal Women

A Phase I/II Study of Preoperative (Neoadjuvant) Combination of Letrozole (Femara), Everolimus (Afinitor), and TRC105 in Postmenopausal Women With Newly Diagnosed Local or Locally Advanced Potentially Resectable Hormone-Receptor Positive and Her2 Negative Breast Cancer (NCT02520063)

Summary

Letrozole (Femara®) is used to treat postmenopausal women with hormone-positive breast cancer. Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It is used to treat advanced HR-positive, HER2-negative breast cancer. TRC105 is an experimental drug that keeps cancer cells from growing the blood vessels they need to survive. Giving therapy before surgery (called neoadjuvant treatment) allows researchers to study the effect that the therapy has on the tumor. This study is investigating the safety and efficacy of giving Femara, Afinitor, and TRC105 before surgery to treat postmenopausal women with HR+, HER2-, stage II or III breast cancer.
This is a Phase I-II trial

Dasatinib Before Surgery for Women with Triple-Negative Breast Cancer

Window of Opportunity Study of Dasatinib in Operable Triple Negative Breast Cancers With Nuclear Epidermal Growth Factor Receptor (NCT02720185)

Summary

To take part in this study, you must be diagnosed with triple-negative breast cancer that can be removed by surgery. You must also have a tumor that is tested and found to be nuclear EGFR-positive. Giving treatment before surgery (called neoadjuvant treatment) allows researchers to study the effect the drug has on your cancer cells. If you enroll in this study, you will receive the drug dasatinib (Sprycel®) before receiving the standard of care treatment for triple-negative breast cancer. Sprycel is used to treat a type of leukemia. It is not yet known if it will also be an effective treatment for breast cancer.
This is a Phase II trial

Femara & Ribociclib Before Surgery in ER+, HER2- Stage II-III Postmenopausal Breast Cancer

Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women With ER-positive, HER2-negative Early Breast Cancer (NCT02712723)

Summary

Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is used to treat early-stage and metastatic breast cancer in postmenopausal women. Ribociclib (LEE011) is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It blocks two enzymes, CDK4 and CDK6, that help cancer cells grow. Giving chemotherapy before surgery--called neoadjuvant treatment--allows researchers to study how well the tumor responds to a treatment. This study is investigating the best dose and effectiveness of ribociclib when it is used with Femara before surgery to treat stage II-III breast cancer. To be eligible, patients must be postmenopausal.
This is a Phase II trial

Neratinib & Imodium after Herceptin for HER2+ Stage I-III 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

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

Ibrance Before Surgery for HR-Positive Stage I-III Breast Cancer

Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS): A Randomized Phase II Study of Palbociclib With Letrozole Versus Letrozole Alone for Invasive Lobular Carcinoma and Invasive Ductal Carcinoma (NCT02764541)

Summary

Palbociclib (Ibrance®) is a targeted therapy that keeps cancer cells from growing by blocking two proteins, CDK4 and CDK6. Tamoxifen (Nolvadex®) and letrozole (Femara®) are hormone therapies commonly used to treat hormone sensitive breast cancer. Giving drugs before surgery is called neoadjuvant therapy. It allows researchers to study the affect the drugs have on the tumor. This study is looking at the safety and effectiveness of using the drug Ibrance along with an hormone therapy to treat breast cancer. To take part, your tumor must be hormone-sensitive and HER2-negative and at least 1.5cm in size. The drugs will be given to you before you have surgery.
This is a Phase II trial

Faslodex & Ibrance for Women & Men Age 70 & Older with Stage I-III Breast Cancer

Phase II Trial of Primary Endocrine Therapy With Combination of Fulvestrant and Palbociclib in Elderly Patients With Hormone Responsive Breast Cancer Who Have Inoperable Tumor Or Operable Tumor But Cannot Undergo Surgery Due to Frailty Or Who Refuse Surgery (NCT02760030)

Summary

Some older women and men who are diagnosed with early-stage breast cancer are not able to have surgery. Two drugs now used to treat breast cancer that has spread to other parts of the body may be a good treatment option for these patients. The drugs are called fulvestrant (Faslodex®) and palbociclib (Ibrance®). To take part in this study, you must be age 70 or older, have a stage I-III, hormone receptor positive (HR+), HER2-negative breast cancer, and cannot or do not want to have surgery.

Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat metastatic HER+ tumors in postmenopausal women. Palbociclib (Ibrance®) is a type of drug called a targeted therapy. It keeps cancer cells from growing by blocking two enzymes, CDK4 and CDK6.
This is a Phase II 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

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 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

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

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

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

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

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 O 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

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

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 women with recurrent triple negative (ER-, PR-, HER2-) breast cancer. This study also is enrolling women 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

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

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.
This is a Phase II trial

Ibrance and Hormone Therapy After Neoadjuvant Chemo & Surgery in HR+, HER2- Breast Cancer

Phase III Study Evaluating Palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in Patients With Hormone-receptor-positive, HER2-normal Primary Breast Cancer With High Relapse Risk After Neoadjuvant Chemotherapy "PENELOPEB" (NCT01864746)

Summary

One in three women with HR+, HER2- breast cancer will still have some tumor remaining after completing a taxane-containing neoadjuvant chemotherapy regimen. Studies suggest these women are at increased risk of a breast cancer recurrence. Palbociclib (Ibrance®) is a new type of targeted therapy called a CDK4/6 protein inhibitor. Ibrance is approved by the FDA to treat postmenopausal women with HR+, HER2- metastatic breast cancer. This study is looking at whether it is better to use Ibrance and hormone therapy than hormone therapy alone after surgery to treat women who did not have a complete response to a neoadjuvant taxane-containing chemotherapy regimen. To be eligible, a woman must have a CPS-EG (clinical-pathologic stage-estrogen/grade) score of >=3 or a score of 2 plus positive nodes.
This is a Phase III trial

Safety of HER2-Targeted Therapies in Patients with Mildly Decreased Heart Function

SAFE-HEaRt: A Pilot Study Assessing the Cardiac SAFEty of HER2 Targeted Therapy in Patients With HER2 Positive Breast Cancer and Reduced Left Ventricular Function (NCT01904903)

Summary

The HER2 targeted therapies—trastuzumab (Herceptin®), pertuzumab (Perjeta®) and ado-trastuzumab emtansine (Kadcyla®)—may cause heart problems in some patients. These drugs are currently approved only for patients with normal heart functioning. It may be possible for HER2+ patients with mildly decreased heart function to also safely use a HER2-targeted therapy. This study is looking at the safety of giving a HER2–targeted therapy to patients with mildly decreased heart function when these patients are evaluated regularly by a cardiologist and take heart medication. To be eligible, participants must have HER2–positive breast cancer and mildly decreased heart function.
This is a Phase II trial

Kadcyla in Patients 65 Years and Older with Stage I-III HER2+ Breast Cancer

Adjuvant Ado-Trastuzumab Emtansine (T-DM1) for Older Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (NCT02414646)

Summary

T-DM1 (Kadcyla®) is approved by the FDA for treating 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 looking at the safety and effectiveness of using Kadcyla after surgery to prevent recurrence in patients 65 years and older who have stage I-III, HER2-positive breast cancer. To be eligible, the patient must have declined standard chemotherapy/Herceptin or not be a candidate for standard therapy.
This is a Phase II trial

Kadcyla and Perjeta Before Surgery in Stage II & III HER2-Positive Breast Cancer

The Impact of HER2 Heterogeneity on the Treatment of Early-stage HER2-positive Breast Cancer: a Phase II Study of T-DM1 in Combination With Pertuzumab in the Preoperative Setting (NCT02326974)

Summary

T-DM1 (Kadcyla®) combines the chemotherapy drug DM1 with the HER2-targeted therapy trastuzumab (Herceptin®). This allows the chemotherapy drug to be delivered directly to the cancer cells. Pertuzumab (Perjeta®) is approved to treat patients with advanced HER2+ breast cancer. It is also approved as a neoadjuvant (before surgery) treatment for patients with HER2+ early-stage breast cancer who are at high risk for recurrence. Giving chemotherapy before surgery (neoadjuvant treatment) allows researchers to study the effect that a treatment has on the breast tumor. This study is evaluating the safety and effectiveness of giving Kadcyla along with Perjeta before surgery to patients with HER2+ stage II or stage III breast cancer.
This is a Phase II trial

Ibrance & Femara Before Surgery in Postmenopausal Women with ER+, HER2- Breast Cancer

A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer (NCT02296801)

Summary

Researchers are studying the best way to treat ER-positive, HER2-negative breast cancer. Giving a treatment before surgery--called neoadjuvant therapy--allows the researchers to study the effect that the treatment has on cancer cells. Palbociclib (Ibrance®) is a new type of targeted therapy called a CDK inhibitor. It blocks two enzymes, CDK4 and CDK6, that play a role in cell growth. It was approved by the FDA in February 2015 for treating postmenopausal women with advanced breast cancer. Letrozole (Femara®) is an aromatase inhibitor, a type of anti-estrogen therapy commonly used to treat postmenopausal women with hormone-sensitive breast cancer. This study is looking at the effect that Femara with or without Inbrance has on cancer cells when it is given before surgery to postmenopausal women with ER+ and HER2- breast cancer.
This is a Phase II 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