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Advanced/Metastatic Breast Cancer
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Hormone therapy

Hormone therapy for breast cancer is used to block the hormones that fuel tumors that are estrogen receptor-positive (ER+) and/or progesterone receptor-positive (PR+).

Femara® Before Surgery in Postmenopausal Women With ER+ DCIS

Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ (NCT01439711)

Summary

Giving endocrine therapy before surgery (called neoadjuvant therapy) allows researchers to monitor how ductal carcinoma in situ (DCIS) responds to treatment. If the DCIS shrinks sufficiently in size, it also may permit the surgeon to perform a lumpectomy instead of a mastectomy. Letrozole (Femara®) is a type of anti-estrogen therapy called an aromatase inhibitor. It is currently used to treat invasive breast cancer. This trial is studying how estrogen-receptor positive (ER+) DCIS responds to Femara when it is given prior to surgery, and whether 3 months of Femara shrinks DCIS size as much as 6 months does. To be eligible for this study, women must be postmenopausal.
This is a Phase II trial

Alisertib and Faslodex for Hormone-Sensitive Advanced Breast Cancer

A Phase I Trial to Evaluate the Safety of the Addition of Alisertib to Fulvestrant in Women With Advanced Hormone Receptor Positive (HR+) Breast Cancer (NCT02219789)

Summary

Researchers are developing new treatments for advanced breast cancer. Alisertib (MLN8237) is a new type of cancer drug that works by blocking an enzyme called Aurora A kinase. Fulvestrant (Falsodex®) is used to treat advanced hormone-sensitive breast cancer in postmenopausal women whose tumors have stopped responding to other hormone therapies. This study will identify the best dose and effectiveness of alisertib when used along with Faslodex to treat advanced hormone-sensitive breast cancer.
This is a Phase I trial

Endoxifen for Locally Recurrent or Metastatic Breast Cancer

Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer (NCT01327781)

Summary

The anti-estrogen drug tamoxifen fights breast cancer by keeping estrogen from getting into the tumor's cells. Before tamoxifen can begin working inside the body, it must be turned into a chemical called endoxifen by a protein in the liver called CYP2D6. Researchers believe that endoxifen may be an effective therapy for women who do not produce enough CYP2D6 to convert tamoxifen into endoxifen. The goal of this study is determine the best dose, effectiveness, and side effects of endoxifen when it is given to women with locally recurrent or metastatic estrogen receptor-positive breast cancer.
This is a Phase I trial

Perjeta and Herceptin with Chemotherapy Before Surgery For HER2+ Breast Cancer

A Multicenter, Multinational, Phase II Study to Evaluate Pertuzumab in Combination With Trastuzumab and Standard Neoadjuvant Anthracycline-based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer (NCT02132949)

Summary

Researchers are trying to find the best drug combinations for treating HER2-positive breast cancer. Giving chemotherapy before surgery (called neoadjuvant treatment) allows researchers to study the effect that anti-cancer drugs have on cancer cells. Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are targeted therapies used to treat HER2-positive tumors. There are chemotherapy regimens commonly used to treat breast cancer. One regimen includes doxorubicin (Adriamycin®), cyclophosphamide (Cytoxan®), and paclitaxel (Taxol®). Another includes 5-fluorouracil (5-FU), epirubicin (Ellence®), Cytoxan and docetaxel (Taxotere®). This study is looking at the effect of giving Perjeta, Herceptin and one of these chemotherapy regimens before surgery to patients with HER2+ breast cancer. (The regimen will be chosen by the patient's doctor.) To be eligible, participants with inflammatory breast cancer must be able to have a core needle biopsy.

Hormone Therapy & Afinitor in Breast Cancer Patients at High Risk for Recurrence

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer (NCT01674140)

Summary

Using two cancer treatments that work in different ways may be a more effective way to treat certain types of breast tumors. Everolimus (Afinitor®) is a newer type of targeted therapy called an mTOR inhibitor. It is used along with the hormone therapy exemestane (Aromasin®) to treat advanced ER+, HER2- breast cancer. Researchers are interested in seeing if Afinitor will be beneficial to women with early-stage breast cancer. This study is looking at whether using one year of Afinitor along with standard hormone therapy is more effective than standard hormone therapy alone in patients with ER+, HER2- breast cancer who are at high risk for recurrence.
This is a Phase III trial

Letrozole Before Surgery in Postmenopausal Women

Letrozole in Treating Postmenopausal Women With Stage I or Stage II Breast Cancer That Can Be Removed by Surgery (NCT00651976)

Summary

Tailoring treatment to an individual’s breast cancer is the goal of personalized medicine. For this to occur, scientists must identify biomarkers that are associated with different types of breast cancer. Ki67 is a biomarker protein that is associated with cell growth. Oncotype DX is a test that is done on tumor tissue that provides information about a woman's risk of recurrence. In this study, researchers are giving the anti-estrogen therapy letrozole (Femara®) to women with ER-positive, HER2-negative tumors before surgery so that they can investigate whether the drug lowers a tumor's Ki67 level. They will also study whether the level of reduction correlates with the tumor's OncotypeDX recurrence score. This information will be used to help develop new ways of assessing a woman's risk of experiencing a breast cancer recurrence.

The Effect of Oral Proellex on Breast Cancer Cells

Presurgical Phase IIB Trial of Oral CDB-4124 vs. Placebo in Women With Stage I-II Primary Breast Cancer (NCT01800422)

Summary

CDB-4124 (Proellex®) is a drug that blocks the progesterone receptor that may have a role in breast cancer treatment. Other clinical trials are currently under way that are studying whether it is effective in reducing symptoms associated with uterine fibroids and endometriosis. In this study, women with stage I or stage II tumors will be given Proellex or a placebo before surgery. The researchers will study the breast tissue removed during surgery to see how Proellex affected the breast cancer cells.
This is a Phase II trial

AZD2014 and Fulvestrant in ER+ Metastatic Breast Cancer

A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With...(NCT01597388)

Summary

Researchers are investigating new drugs and new drug combinations that may be effective against metastatic breast cancer. AZD2014 is an investigational drug that works by inhibiting two pathways that fuel cancer growth: mTORC1 and mTORC2. Fulvestrant (Faslodex®) is approved by the U.S. Food and Drug Administration to treat postmenopausal women with metastatic hormone-sensitive breast cancer that has stopped responding to other hormonal therapy. The purpose of this study is to assess the safety and tolerability of AZD2014 when it is given in combination with Faslodex to women with hormone-sensitive metastatic breast cancer that has already been treated with other hormonal therapies.
This is a Phase I trial

Study of Tamoxifen Effectiveness on Treating Advanced Disease

Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer (NCT01124695)

Summary

Tamoxifen is one of the anti-estrogen therapies used to treat early and advanced stage breast cancer. CYP2D6 is an enzyme that breaks down tamoxifen into metabolites that your body can use. People have different levels of CYP2D6. Studies have found that people with high levels of CYP2D6 metabolize tamoxifen quickly, whereas those with low levels metabolize tamoxifen more slowly. Researchers believe that the rate of tamoxifen metabolism may have an effect on how well tamoxifen works. The purpose of this study is to determine if there is a correlation between levels of CYP2D6 and how well tamoxifen works in individuals with recurrent or metastatic breast cancer.
This is a Phase II trial

Aromasin® and Cytoxan® for Hormone Sensitive Metastatic Breast Cancer

Phase II Trial of Exemestane With Immunomodulatory Cyclophosphamide in ER and/or PR-positive and HER2/Neu Negative Metastatic Breast Cancer (NCT01963481)

Summary

Exemestane (Aromasin®) is an aromatase inhibitor that is used to treat hormone-sensitive breast cancer. Cyclophosphamide (Cytoxan®) is a chemotherapy drug used to treat breast cancer. Researchers believe that giving Cytoxan at a low dose may stimulate the white blood cells, making the Aromain more effective. This study is investigating the safety and effectiveness of using Aromasin and Cytoxan to treat women with metastatic ER+, PR+, HER2- breast cancer.
This is a Phase II trial

Enzalutamide For Treating Metastatic Breast Cancer

A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of MDV3100 in Patients With Incurable Breast Cancer (NCT01597193)

Summary

Many breast cancers depend on the hormones estrogen and/or progesterone to grow and spread. Research suggests that the androgen receptor (AR) is an additional hormonal target in many breast cancers. Blocking androgen from getting into AR+ breast tumors may slow or stop tumor growth. Enzalutamide is an experimental drug that can keep androgen from getting into cancer cells. Studies using the drug to treat prostate cancer have shown promising results. In the laboratory, it can also slow breast cancer cell growth. The purpose of this study is to determine the safety and tolerability of enzalutamide in patients with metastatic breast cancer that cannot be treated with other drugs.
This is a Phase I trial

BKM120 After an AI & an mTOR Inhibitor for Advanced Disease

A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on... (NCT01633060)

Summary

Researchers are trying to develop new drugs that will be effective in treating advanced hormone-sensitive tumors. BKM120 is an investigational targeted therapy that works by blocking PI3K, a group of proteins that help cancer cells to grow, possibly by increasing their resistance to hormone therapy. Fulvestrant (Faslodex®) is used to treat advanced hormone-sensitive breast cancer in postmenopausal women whose tumors have stopped responding to other anti-estrogen therapies. This study is comparing the safety and effectiveness of BKM120 and Faslodex to Faslodex and a placebo in women with HER2-negative advanced breast cancer who have previously been treated with an mTOR inhibitor, such as Everolimus (Afinitor®).
This is a Phase III trial

Faslodex, Afinitor and Arimidex in Post-Menopausal Women with Metastatic Breast Cancer

Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial in Postmenopausal Patients (NCT02137837)

Summary

Researchers are trying to identify the best drug combinations for treating postmenopausal women with hormone sensitive metastatic breast cancer. Anastrozole (Arimidex®) is one of the aromatase inhibitors used to treat postmenopausal hormone-sensitive breast cancer. Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat postmenopausal women with metastatic hormone-sensitive breast cancer that has stopped responding to other hormonal therapies. Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It is used along with hormone therapy to treat advanced ER+, HER2- breast cancer. This trial is comparing the effectiveness of Faslodex alone; Faslodex and Afinitor; and Faslodex, Afinitor and Arimidex in postmenopausal women with hormone-sensitive metastatic breast cancer.
This is a Phase III trial

Endoxifen For Hormone Receptor-Positive Metastatic Disease

Phase I Trial of Z-Endoxifen in Adults With Refractory Hormone Receptor-Positive Breast Cancer, Desmoid Tumors, Gynecologic Tumors, or Other Hormone Receptor-Positive Solid Tumors (NCT01273168)

Summary

Some hormone-sensitive tumors do not respond to the anti-estrogen drug tamoxifen. Tamoxifen begins working after a protein in the liver called CYP2D6 turns it into endoxifen. Studies have shown that some women do not produce enough CYP2D6 to turn tamoxifen into endoxifen. Researchers think that giving endoxifen directly may overcome this problem. The purpose of this trial is to test the safety and effectiveness of endoxifen in women with hormone receptor-positive metastatic disease that has not responded to standard treatment.
This is a Phase I trial

Arimidex® and Fulvestrant Before Surgery

Combined Fulvestrant and Anastrozole as Neo-adjuvant Endocrine Therapy in Postmenopausal Women With Hormone Receptor Positive Invasive Breast Cancer (NCT00921115) (NCT00921115)

Summary

Tumors that are hormone sensitive are treated with anti-estrogen drugs. Anastrozole (Arimidex®) is a type of hormone therapy that works by stopping the production of estrogen. It is currently used to treat postmenopausal women with early-stage or advanced hormone-sensitive breast cancer. Fulvestrant (Faslodex®) is a type of hormone therapy that works by blocking the estrogen receptor. It is currently used to treat postmenopausal women with hormone-sensitive tumors that have stopped responding to other anti-estrogen therapies. The goal of this trial is to study the effectiveness of the combination of Arimidex® and fulvestrant when it is given before surgery to women with Stage II or III breast cancer. To be eligible, participants must have their tumor evaluated with the Oncotype DX test and receive a low or intermediate score.
This is a Phase II trial

BYL719 Plus Femara® or Aromasin® for Hormone-Sensitive Advanced Breast Cancer

A Phase I Trial of BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer (NCT01870505)

Summary

Letrozole (Femara®) and exemestane (Aromasin®) are hormone therapies used to treat postmenopausal women with advanced breast cancer. As with other drugs, over time, the breast cancer can stop responding to these treatments. BYL719 is a new drug that blocks PI3 kinase, an enzyme that helps breast cancer cells grow. This study will determine the highest dose of BYL719 that can be given safely along with Femara or Aromasin. To be eligible for this study, a woman must currently be taking Femara or Aromasin to treat locally advanced or metastatic breast cancer.
This is a Phase I trial

Arimidex & Faslodex Before Surgery for Stage II-III ER+, HER2- Breast Cancer

Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study (NCT01953588)

Summary

Giving therapy before surgery--called neoadjuvant treatment--allows researchers to study how the treatment affects the breast tumor. Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat postmenopausal women with metastatic hormone-sensitive tumors. Anastrozole (Arimidex®) is anti-estrogen therapy used to treat postmenopausal women with hormone-sensitive breast cancer. This study is locking at the effect that Arimidex alone, Faslodex alone, or Arimidex and Falsodex in combination have on the tumor when they are given before surgery to postmenopausal women with stage II-III ER-positive, HER2-negative breast cancer.
This is a Phase III trial

Arimidex and Faslodex in Postmenopausal Women with ER+ Tumors

A Phase II Trial of Neoadjuvant Arimidex With or Without Faslodex in Postmenopausal Women With Hormone Receptor Positive Breast Cancer (NCT00570323)

Summary

Anti-estrogen hormone therapies are used to treat tumors that are hormone-sensitive. It is possible that using two hormone therapies with different mechanisms of action may be more effective than using one drug alone. Fulvestrant (Faslodex®) works by attaching to a cell's estrogen receptors, which blocks estrogen from getting into the cell. It also reduces (downregulates) the number of estrogen receptors. Anastrozole (Arimidex®) lowers estrogen levels by blocking an enzyme called aromatase, which is needed to synthesize estrogen. The goal of this trial is to see whether a combination of fulvestrant and anastrozole is more beneficial than anastrozole alone. This concept will be tested by giving hormone therapy prior to surgery to newly diagnosed, post-menopausal women with hormone receptor-positive 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

Everolimus Plus Femara in ER+ Advanced Breast Cancer

An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Metastatic Breast Cancer (NCT01698918)

Summary

Everolimus (Afinitor®) is a new type of targeted therapy. It is currently used along with exemestane (Aromasin®) to treat postmenopausal women with advanced hormone-sensitive, HER2- breast cancer. This study is looking at the safety and effectiveness of using everolimus (Afinitor®) with letrozole (Femara®) to treat these postmenopausal women. Study volunteers will be be given Afinitor and Aromasin if/when their breast cancer progresses. The study is also looking at whether a mouth rinse can help reduce mouth irritation, a common side effect of Afinitor.
This is a Phase II 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. Y2835219 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

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

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

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

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

A Phase II, Single Arm Study of the Use of Steroid-based Mouthwash to Prevent Stomatitis in Postmenopausal Women With Advanced or Metastatic Hormone Receptor Positive Breast Cancer Being Treated With Everolimus Plus Exemestane (NCT02069093) (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

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

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

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

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

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

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

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

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

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

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

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

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

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

LEE011, BYL719 & Femara for Advanced ER+/HER2- Breast Cancer

A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer (NCT01872260)

Summary

Researchers are looking for new targeted therapies and new drug combinations that will be effective breast cancer treatments. LEE011 and BYL719 are two new targeted therapies that may slow or stop breast cancer growth. LEE011 works by blocking two enzymes, called CDK4 and CDK6, that are needed for cell growth. BYL719 works by blocking a protein called PI3K that plays a role in tumor growth. Letrozole (Femara®) is an anti-estrogen drug that is routinely used to treat hormone-sensitive tumors. Previous studies have shown that combining a targeted therapy with an anti-estrogen drug may prevent breast cancer cells from developing resistance to hormone therapy. This study is comparing the safety and effectiveness of using LEE011 and BYL719 alone or in combination with Femara to treat ER+/HER2- locally advanced or metastatic breast cancer.
This is a Phase I-II trial

Xtandi and Aromasin in Hormone-Sensitive Advanced Breast Cancer

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor-Positive and HER2-Normal (NCT02007512)

Summary

Many breast tumors that are hormone sensitive (ER-positive and/or PR-positive) also have androgen receptors. Laboratory studies suggest that advanced hormone-sensitive tumors that are not responding to anti-estrogen therapies may respond to a drug that blocks the androgen receptor. Enzalutamide (Xtandi®) targets the androgen receptor. It is approved for the treatment of metastatic prostate cancer. Exemestane (Aromasin®) is an anti-estrogen drug used to treat ER+ breast cancer in postmenopausal women. This study is looking at whether it is safe and effective to give Xtandi along with Aromasin to postmenopausal women with advanced breast cancer.
This is a Phase II trial

Finding Biomarkers to Predict Which Tumors Will Respond to Tamoxifen

Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients (NCT01027416)

Summary

Tamoxifen is the standard of care for premenopausal women with hormone-positive breast cancer. Researchers are trying to identify biological markers (biomarkers) that can help them identify which women will benefit from tamoxifen. The p53 gene makes the p53 protein. Previous studies have shown that tumors that contain an abnormal p53 protein may not respond to tamoxifen. This study will investigate how tamoxifen affects p53 and other biomarkers by studying blood and tumor samples taken from women who are given tamoxifen before surgery. To be eligible for this study, a woman must be premenopausal, have hormone-positive breast cancer, and have a tumor that tests positive for the abnormal p53 protein.

Circulating Tumor Cells to Predict Response to Hormone Therapy

COMETI Phase 2: Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index (NCT01701050)

Summary

Studies have found that between 30 and 50 percent of patients with hormone-sensitive metastatic breast cancer respond to hormone therapy, and that between 15 and 30 percent of these patients progress in the first 2-3 months. There is currently no way to tell before treatment begins which patients will benefit. Researchers are trying to develop a way to use biological markers (biomarkers) found in circulating tumor cells (CTC) to determine which patients will respond to treatment. The purpose of this study is to see whether it is possible to use four specific biomarkers to identify which patients with metastatic breast cancer will benefit from hormone therapy. To be eligible, participants must be planning to start a new line of hormone therapy.

Measuring Breast Density in Premenopausal Breast Cancer Patients on Tamoxifen

Development of a Quantitative Tissue Optical Index of Breast Density (NCT01773551)

Summary

Some studies have suggested that premenopausal breast cancer patients whose breasts become less dense (as measured by a mammogram) while they are on tamoxifen are less likely to have a recurrence than women on tamoxifen whose breast density does not change. Researchers have developed a new tool called diffuse optical spectroscopic imaging that uses light to measure tissue thickness. This study is looking at whether this new tool can be used to measure changes in breast density. To be eligible, a woman must be premenopausal and taking tamoxifen to treat stage I - III breast cancer.