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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+).

Xtandi and Taxol for Advanced Triple Negative Breast Cancer

A Phase 3, Randomized, International Study Comparing the Efficacy and Safety of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer (NCT02929576)

Summary

To take part in this study, you must have been diagnosed with locally advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. This study is comparing three different treatment regimens for advanced triple negative breast cancer: Enzalutamide (Xtandi®) and Paclitaxel (Taxol®) together; Xtandi followed by Taxol, and Taxol alone. Xtandi is currently used to treat prostate cancer. Studies suggest it may also be effective as a breast cancer treatment. Taxol is a chemotherapy drug used to treat advanced breast cancer.
This is a Phase III trial

Keytruda + Chemo or an Aromatase Inhibitor for HER2-Negative Metastatic Breast Cancer

MK-3475 (Pembrolizumab) in Combination With an Anthracycline or Anti-estrogen Therapy in Patients With Triple Negative and Hormone Receptor Positive (HR+ HER2-) Metastatic Breast Cancer (NCT02648477)

Summary

Pembrolizumab (Keytruda®) is an immunotherapy drug that targets the programmed cell death (PD-1) protein. Blocking this protein allows the body's immune system to attack cancer cells. Doxorubicin (Adriamycin®) is a chemotherapy drug commonly used to treat breast cancer. Aromatase inhibitors (anastrozole/Arimidex®, letrozole/Femara®, exemestane/Aromasin®) are used to treat hormone-sensitive tumors in postmenopausal women. This study is investigating the safety and effectiveness of using Keytruda to treat HER2-negative metastatic breast cancer. In this study, patients with triple-negative tumors will receive Adriamycin along with Keytruda, while patients with hormone-sensitive tumors will receive an AI along with Keytruda.To be eligible, participants must not have been treated previously with Keytruda.
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.

Xtandi and Taxol Before Surgery for Stage I-III Triple-Negative Breast Cancer

A Phase IIB Study of Neoadjuvant Enzalutamide (ZT) Regimen Therapy in Combination With Weekly Paclitaxel for Androgen Receptor (AR)-Positive Triple-Negative Breast Cancer(NCT02689427)

Summary

To take part in this study, you must have stage I-III triple negative breast cancer (ER-, PR- and HER2-). Your tumor must also be androgen receptor positive (AR+). This study is looking at the safety and effect of giving an anti-androgen drug along with chemotherapy before surgery to patients with triple negative breast cancer. This will allow the researchers to study the effect the drugs have on your breast tumor. If you are enroll in the study, your tumor will be tested to see if is AR+. You can only stay in the study if your tumor is AR+. Androgen receptors (AR) are found on many triple-negative breast tumors. Researchers think drugs that block these receptors could keep breast cancer cells from growing. The anti-androgen drug that will be used in this study is enzalutamide (Xtandi®). It is currently used to treat prostate cancer. It will be given with paclitaxel (Taxol®), a chemotherapy drug used to treat breast cancer.
This is a Phase II trial

Enobosarm for Advanced ER-Positive and Androgen Receptor-Positive Breast Cancer

A Phase 2 Open Label, Multi-Center, Multinational, Randomized, Parallel Design Study Investigating The Efficacy and Safety Of GTx-024 On Metastatic or Locally Advanced ER+/AR+ Breast Cancer (BC) in Postmenopausal Women (NCT02463032)

Summary

More than 80% of patients with metastatic ER-positive breast cancer have tumors that are also androgen receptor (AR) positive. Enobosarm (Ostarine®/GTx-024) is a new type of drug called a selective androgen receptor modulator. Early studies suggest that enobosarm may be an effective treatment for metastatic AR+, ER+ breast cancer. This study is investigating the safety, effectiveness, and best dose of enobosarm in treating advanced ER+, AR+ breast cancer in postmenopausal women.
This is a Phase II trial

VT-464 for Androgen Receptor-Positive Advanced Breast Cancer

A Phase 1/2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of VT-464 in Patients With Advanced Breast Cancer (NCT02580448)

Summary

VT-464 is an experimental drug that slows cancer cell growth by blocking the androgen receptor (AR). It is currently being studied in prostate cancer. Researchers think VT-464 may be an effective treatment for certain types of breast cancer. This study is evaluating the safety and efficacy of VT-464 to treat advanced breast cancer. The phase I part of the study will enroll women with triple-negative or ER+/HER2- breast cancer. The phase II part of the study will enroll women with AR+/triple-negative or ER+/HER2- tumor.
This is a Phase I-II trial

Endoxifen or Tamoxifen for Advanced ER+, HER2- Breast Cancer

A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women With Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer (NCT02311933)

Summary

Hormone sensitive tumors are treated with anti-estrogen therapies. Tamoxifen (Nolvadex®) is an anti-estrogen therapy routinely used to treat early-stage and metastatic breast cancer. Endoxifen (z-endoxifen hydrochloride) is an active metabolite of tamoxifen. Scientists think that endoxifen may be a more effective anti-estrogen therapy than tamoxifen. This study is comparing the safety and effectiveness of tamoxifen to endoxifen for treating ER+, HER2- locally advanced or metastatic breast cancer. To be eligible, patents must have been previously treated with an aromatase inhibitor—letrozole (Femara®), anastrozole (Arimidex®) or exemestane (Aromasin®)– in the adjuvant or metastatic setting and have an endocrine-resistant tumor.
This is a Phase II trial

GDC-0810 or Faslodex for ER+, HER2- Advanced Breast Cancer Already Treated With an AI

A Study of GDC-0810 Versus Fulvestrant in Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy (HydranGea) (NCT02569801)

Summary

GDC-0810 is an investigational drug called a selective estrogen receptor degrader (SERD) being studied in tumors that are ER-positive. Fulvestrant (Faslodex®) is a hormone therapy used to treat ER+ metastatic breast cancer in postmenopausal women who have tried other hormone therapies. In this study, researchers are comparing the safety and efficacy of GDC-0810 and Faslodex in women with advanced ER+, HER2- breast cancer whose cancer has progressed following treatment with an aromatase inhibitor.
This is a Phase II trial

Estrogen and an Aromatase Inhibitor in Advanced ER+ Breast Cancer

Phase II Pre-emptive OsciLLation of ER activitY Levels Through Alternation of Estradiol/Anti-estrogen Therapies Prior to Disease Progression in ER+/HER2- Advanced Breast Cancer (NCT02188745)

Summary

Anti-estrogen therapies are used to treat ER+ tumors. However, over time, these tumors can stop responding to these treatments. Laboratory studies suggest that giving a high dose of estrogen to patients whose tumors have stopped responding to an anti-estrogen therapy may get the tumor to respond again to the treatment. This study will investigate how tumors respond when estrogen (17B-estradiol) is given along with an aromatase inhibitor––letrozole (Femara®), anastrozole (Arimidex®) or exemestane (Aromasin®) to treat women with advanced ER+, HER2- metastatic breast cancer. To be eligible for this study, a patient must have been previously treated with tamoxifen, raloxifene, toremifene, or an AI.
This is a Phase II trial

Weight & the Effect of Hormone Therapy Given Before Surgery for Stage I-III Breast Cancer

GCC 1366: A Prospective Study of Neoadjuvant Non-Steroidal Aromatase Inhibitors to Evaluate Anti-Proliferative Response in Obese and Overweight Patients(NCT02095184)

Summary

To take part in this study, you must be postmenopausal and have stage I, II or III breast cancer that is ER-positive and HER2-negative. In addition, your tumor must be ≥ 2.0 cm and your doctor must have told you it can be removed with surgery. This study is looking at whether a woman's weight—normal, overweight, obese—affects how her breast cancer cells respond to anti-estrogen drugs. The two drugs being used in this study are anastrozole (Arimidex®) and letrozole (Femara®). Both drugs are used to treat hormone-sensitive tumors in postmenopausal women. In order to study how the breast cancer cells respond, the treatment is given before surgery. This is called neoadjuvant therapy.

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-II trial

FDG-PET/CT Imaging to Monitor Bone Metastases in Individuals Taking Hormone Therapy

18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) For The Evaluation Of Response To Therapy In Bone-Dominant Metastatic Breast Cancer (NCT02110160)

Summary

FDG-PET/CT uses two imaging techniques at the same time, providing a more detailed assessment of how organs and tissues are functioning. This study is investigating whether FDG PET/CT imaging is an effective way to evaluate how bone metastases respond to hormone therapy. To be eligible, patients must have ER+ metastatic breast cancer that has spread predominantly to the bone and must be planning to start a new hormone therapy.

Faslodex or Tamoxifen for ER-Positive Metastatic Breast Cancer

Treatment of Metastatic Breast Cancer With Fulvestrant or Tamoxifen: A Randomized Phase II Trial With ESR1 Mutation Tested in Circulating Tumor DNA (NCT02913430)

Summary

To take part in this study, you must have ER-positive metastatic breast cancer. You must also have not been treated with Faslodex or tamoxifen since being diagnosed with metastatic breast cancer. This study is comparing how well two different anti-estrogen drugs keep metastatic breast cancer from spreading. The two drugs are fulvestrant (Faslodex®) and tamoxifen (Nolvadex®). Both are used to treat metastatic breast cancer. The researchers will use blood tests to study each patient's circulating tumor DNA—DNA from the cancer that floats in the blood stream—in order to learn more about a mutation called ESR1 and why hormone-sensitive tumors stop responding to anti-estrogen treatments.
This is a Phase II trial

Effect of Faslodex When Given Before Surgery in ER+ DCIS or Early-Stage Breast Cancer

An Open Label, Phase 2 Pharmacokinetic Study of Pre-Surgical Intramuscular and Intraductal Fulvestrant in Women With Invasive Breast Cancer or DCIS Undergoing Mastectomy (NCT02540330)

Summary

Fulvestrant (Faslodex®) is a hormone therapy that is currently used to treat hormone-sensitive (ER+) metastatic breast cancer in postmenopausal women. Researchers are interested in learning the effect that the drug has on DCIS and early-stage breast cancers. They also want to see if the drug has different effects when it is injected into a muscle (how it is used now) or injected directly into the milk ducts, where cancer begins (this is called intraductal therapy). In this study, researchers will compare the safety and effectiveness of Faslodex when it is given before surgery through the muscle or milk duct of women with DCIS or early-stage hormone-sensitive breast cancer. To be eligible, patients must be scheduled to have a surgery within one month.
This is a Phase II trial

Xtandi for Stage I-III Triple Negative Androgen Receptor-Positive Breast Cancer

Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer (NCT02750358)

Summary

Drugs that work for other types of cancer may also work for breast cancer. Enzalutamide (Xtandi®) is used to treat prostate cancer. Xtandi slows cancer cell growth by blocking the androgen receptor. This study is looking at what effect Xtandi has when it is used to treat women with early-stage breast cancer who already have had surgery. To take part, you must have stage I-III triple negative breast cancer that also is androgen receptor positive.
This is a Phase II trial

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.

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 therapy that is designed to prevent tumor growth by destroying the estrogen receptor, called selective estrogen receptor degrader. 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

Tamoxifen and Faslodex Before Surgery in Premenopausal Women with ER+ Breast Cancer

Comparison in the Change of Proliferation Index Between Fulvestrant and Tamoxifen in Cyclin D1 +, Estrogen Receptor + Breast Cancer (NCT02936206)

Summary

To take part in this study, you must be premenopausal and newly diagnosed with ER-positive, HER2-negative breast cancer. Your tumors must also be cyclin D1-positive and at least 5 mm in size. You must also be scheduled to have surgery at Mount Sinai Hospital in New York. This study is looking at the effect that two different types of anti-estrogen drugs have on breast cancer cells in premenopausal women. The two drugs being studied are tamoxifen (Nolvadex®) and fulvestrant (Faslodex®). Both are used to treat breast cancer. Giving the drugs before surgery allows the researchers to study the effect they have on breast cancer cells.
This is a Phase I trial

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.

Hormone Therapy Before Surgery for Invasive Lobular Breast Cancer

A Trial of Endocrine Response in Women With Invasive Lobular Breast Cancer (NCT02206984)

Summary

To take part in this study, you must have invasive lobular breast cancer and not yet had surgery. You must also no longer be getting your period (postmenopausal). This study is looking at which anti-estrogen treatment is best to use before surgery in women who have invasive lobular breast cancer. Each patient in the study will receive one of the three anti-estrogen drugs the researchers are studying. These three drugs are tamoxifen (Nolvadex®), anastrozole (Arimidex®), and fulvestrant (Faslodex®).

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

Plaquenil® & Hormone Therapy for ER-Positive Metastatic Breast Cancer

Phase Ib/II Study of Hydroxychloroquine in Metastatic ER-Positive Breast Cancer Progressing on Hormonal Therapy (NCT02414776)

Summary

Over time, hormone-sensitive tumors can stop responding to anti-estrogen therapies. Hydroxychloroquine (Plaquenil®) is a drug used to treat malaria, rheumatoid arthritis, and lupus. Laboratory studies suggest Plaquenil can get hormone-resistant tumors to start responding to an anti-estrogen therapy. This study is exploring the safety and efficacy of giving Plaquenil with an anti-estrogen therapy to patients with ER+ metastatic breast cancer that has progressed on other anti-estrogen therapies. To be eligible, patients must have at least one metastatic lesion that can be evaluated for tumor response. Patients cannot be on combination hormonal therapy with everolimus (Afinitor®) or any other investigational therapies.
This is a Phase I 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

A Study of How Femara® Affects Breast Cancer Cells

Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer. (NCT02010021)

Summary

Letrozole (Femara®) is a hormone therapy that is used to treat postmenopausal women with hormone-sensitive breast cancer. Laboratory studies have found that Femara also promotes cell destruction by interfering with a cellular destruction pathway. Giving a cancer therapy before surgery allows researchers to study the effect that the drug has on the cancer cells. This study will compare tumor tissue removed during surgery from women who took Femara prior to their surgery with tumor tissue taken from women who did not take Femara to learn more about the effect that Femara has on the cellular destruction pathway and on a gene called Ki67 that is associated with the rate of tumor cell growth.

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

Alpelisib and Fulvestrant for HR+, HER2- Advanced Breast Cancer

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. (SOLAR-1) (NCT02437318)

Summary

Scientists are studying new treatments and new treatment combinations for patients with advanced breast cancer that has stopped responding to hormone therapy. Alpelisib (BYL719) is a type of targeted therapy called a PI3K inhibitor. It works by blocking the PI3K pathway. Earlier studies suggest it may be an effective breast cancer treatment. Fulvestrant (Faslodex®) is used to treat postmenopausal women with hormone-sensitive metastatic breast cancer that has stopped responding to other hormone therapy. This study is comparing the safety and effectiveness of Faslodex and Alpelisib with Faslodex and a placebo in men and postmenopausal women with HR+, HER2- advanced breast cancer. To be eligible, participants must have progressed on or after being treated with an aromatase inhibitor.
This is a Phase III trial

Xofigo to Treat Bone Metastases in Hormone-Sensitive, HER2-Negative Breast Cancer

A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases (NCT02258451)

Summary

Radium-223 dichloride (Xofigo®) is an FDA approved drug to treat bone metastasis in prostate cancer. It works by using radioactive particles that mimic calcium to enter the bone and target cancer cells. Everolimus (Afinitor®) and exemestane (Aromasin®) are used together to treat advanced hormone-sensitive, HER2-negative breast cancer. This study is comparing the safety and effectiveness of Xofigo, Afinitor, and Aromasin to a placebo, Afinitor, and Aromasin for reducing bone metastasis in women with hormone-sensitive, HER2-negative breast cancer.
This is a Phase 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

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

AZD2014, Ibrance and Faslodex for Advanced ER+, HER2- Breast Cancer

Ph I/II Multicenter Study of the Combination of AZD2014 and Palbociclib on a Background of Hormonal Therapy in Patients With Locally Adv/Metastatic ER Positive Breast Cancer Comprising a Safety, Pharmacokinetic and Preliminary Efficacy Evaluation Followed by a Randomised, Double-Blind, Placebo-controlled, Parallel Group Extension (NCT02599714)

Summary

AZD2014 is a type of targeted therapy called an mTOR1/2 inhibitor. It works by interfering with a cancer cell's ability to divide and grow. Palociclib (Ibrance®) is an FDA-approved targeted therapy used in combination with the anti-estrogen therapy letrozole (Femara®) to treat metastatic breast cancer. Fulvestrant (Faslodex®) is an anti-estrogen approved to treat advanced breast cancer. This study is comparing the effectiveness of the combination of AZD2014, Ibrance and Faslodex to the combination of Ibrance and Faslodex in patients with advanced ER+, HER2- breast cancer.
This is a Phase I-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

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

Ibrance & Hormone Therapy in Patients with Advanced Breast Cancer

Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive Metastatic Breast Cancer Previously Exposed to Inhibitors of the PI3K Pathway: A Phase II Study With Pharmacodynamics Markers (NCT02384239)

Summary

Palbociclib (Ibrance®) is a targeted therapy that keeps cancer cells from growing by blocking two enzymes, CDK 4 and CDK 6. It is used to treat metastatic breast cancer. Tamoxifen (Nolvadex®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer. Fulvestrant (Faslodex®) is a hormone therapy used in postmenopausal women to treat hormone-sensitive breast cancer that has stopped responding to other hormone therapies. This study is comparing the effectiveness of two different doses of Ibrance -- 100 mg or 125 mg -- when it is given with Faslodex or tamoxifen (physician's choice) to treat patients with advanced breast cancer who have already been treated with an mTOR or PI3K inhibitor.
This is a Phase II trial

Ribociclib and Faslodex for HR+, HER2- Advanced Breast Cancer

A Randomized Phase II Trial of Fulvestrant With or Without Ribociclib After Progression on Aromatase Inhibition Plus Cyclin-dependent Kinase 4/6 Inhibition in Patients With Unresectable or Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT02632045)

Summary

Ribociclib (LEE011) is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It works by inhibiting two enzymes, CDK4 and CDK6. Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat advanced breast cancer in postmenopausal women. This study is comparing the safety and effectiveness of Faslodex and ribocicilib to Faslodex and a placebo for treating HR+, HER2- advanced breast cancer. To be eligible, participants must have had their cancer progress after receiving an aromatase inhibitor (letrozole, exemestane, or anastrozole), and be in the process of switching their hormone therapy.
This is a Phase II trial

Tamoxifen and Ribociclib for Metastatic ER+, HER2- Breast Cancer

The TEEL Study: A Phase I Trial of Tamoxifen With Ribociclib (LEE011) in Adult Patients With Advanced ER+ (HER2 Negative) Breast Cancer (NCT02586675)

Summary

Tamoxifen (Nolvadex®) is an anti-estrogen therapy routinely used to treat breast cancer. Ribociclib (LEE011) is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It works by inhibiting two enzymes, CDK4 and CDK 6. This study is evaluating the safety and effectiveness of using ribociclib along with tamoxifen to treat hormone-sensitive, HER2-negative advanced breast cancer. Premenopausal or perimenopausal women who enroll in this study will also receive goserelin (Zoladex®), a drug that is used to put a woman into temporary menopause. To be eligible, participants must not have already been treated with a CDK 4/6 therapy.
This is a Phase I 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

Entinostat and Aromasin in Postmenopausal Women with ER+ Advanced Breast Cancer

A Phase 1, Two-Cohort, Open-Label, Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer (NCT02820961)

Summary

To take part in this study, you must be postmenopausal, have ER+ locally advanced or metastatic breast cancer, and have your doctor say you are eligible to receive exemestane (Aromasin®). This study is looking at whether it is safe and effective to use Aromasin and entinostat together to treat ER+ advanced breast cancer. Entinostat is a type of experimental therapy called a histone deacetylase (HDAC) inhibitor. It blocks proteins that help tumors grow and survive. Aromasin is used to treat hormone-sensitive tumors in postmenopausal women.
This is a Phase I 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

Ribociclib with Afinitor + Aromasin in HR+ HER2- Advanced Breast Cancer

A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor (NCT02732119)

Summary

Researchers want to learn the best way to treat breast cancer patients who already have been treated with a CDK4/6 targeted therapy. This study is looking at the safety and effectiveness of treating these patients with a three drug combination: ribociclib (LEE011), everolimus (Afinitor®), and exemestane (Aromasin®). Ribociclib (LEE011) is a targeted therapy that blocks CDK4 and CDK6. Afinitor is a type of targeted therapy called an mTOR inhibitor. It is used along with Aromasin to treat advanced hormone sensitive (HR+), HER2- breast cancer. To take part, you must have HR+, HER2- locally recurrent or metastatic breast cancer. You also must already have been treated with fulvestrant/Faslodex® or tamoxifen/Nolvadex® and a CDK4/6-targeted therapy.
This is a Phase I-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

Ibrance and Femara in African-American Women with Advanced HR+ HER2- Breast Cancer

Phase II Safety Study of Palbociclib in Combination With Letrozole in African American Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer (NCT02692755)

Summary

Researchers want to learn more about the safety and effectiveness of breast cancer treatments in African-American women. In this study, women will receive two drugs, palbociclib (Ibrance®) and letrozole (Femara®). The researchers will study the drug's effectiveness. They will also study whether this drug combination increases your risk of developing an infection by lowering your number of white blood cells. This condition is called neutropenia. Ibrance is a targeted therapy that blocks two different enzymes. Femara is a hormone therapy used to treat postmenopausal women with advanced breast cancer. To take part in this study, you must identify as Black, African or African-American and have hormone-sensitive, HER2-negative advanced breast cancer. And, you must not have already been treated with a CDK 4/6 inhibiting therapy.
This is a Phase II-III trial

Gedatolisib with Ibrance and Femara or Faslodex in ER+ HER2- Metastatic Breast Cancer

Phase 1b Study To Assess The Safety, Tolerability, And Clinical Activity Of Gedatolisib In Combination With Palbociclib And Either Letrozole Or Fulvestrant In Women With Metastatic Or Locally Advanced/Recurrent Breast Cancer (MBC) (NCT02684032)

Summary

Researchers are studying new treatment combinations for metastatic breast cancer. Palbociclib (Ibrance®) is a targeted drug that is used to treat metastatic breast cancer. It is given along with hormone therapy--either letrozole (Femara®) or fulvestrant (Faslodex®). This study is looking at the best dose of gedatolisib to add to the combination. To take part in this study, you must have ER-positive and HER2-negative metastatic breast cancer.
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

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

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

Phase II Trial of Radium-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. Radium-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 cancer. 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

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 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

Aromatase Inhibitor & Herceptin & Perjeta in ER+, HER2+ Metastatic Breast Cancer

A Randomized, Two-arm, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-positive and Hormone Receptor-positive Advanced (Metastatic or Locally Advanced) Breast Cancer. (NCT01491737)

Summary

Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are HER2-targeted therapies used to treat HER2+ breast cancer. Aromatase inhibitors are hormone therapies used to treat hormone-sensitive tumors. This study is comparing the safety and effectiveness of Perjeta, Herceptin, an AI, and chemo to Herceptin, an AI, and chemo in patients with metastatic HER2+, ER+ breast cancer. To be eligible, participants must have not yet received treatment for metastatic breast cancer.
This is a Phase II trial

Ibrance and Tamoxifen for HR+, HER2- Advanced Breast Cancer

A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium BTCRC-BRE15-016 (NCT02668666)

Summary

To take part in this study, you must have hormone receptor-positive (ER+/PR+), recurrent stage III or stage IV metastatic breast cancer. You must also have recently received this diagnosis and not yet had any treatment for it. This study is investigating how well a targeted drug along with an anti-estrogen drug work as a first-line treatment for metastatic breast cancer or stage III recurrent breast cancer. The targeted drug being used in this study is palbociclib (Ibrance®). The anti-estrogen drug is tamoxifen (Nolvadex®).
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 hormone-sensitive, HER2-negative advanced breast cancer.
This is a Phase III trial

Abemaciclib and Tamoxifen for HR+, HER2- Metastatic Breast Cancer

A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer(NCT02747004)

Summary

To take part in this study, you must have hormone sensitive (HR+), HER2-negative metastatic breast cancer. You must have already had one anti-estrogen treatment and you must have already been treated with chemotherapy. Abemaciclib (LY2835219) is a new type of cancer treatment called a CDK 4/6 inhibitor. It only is available in clinical trials. This study is comparing the safety and effectiveness of abemaciclib when it is given alone to when it is given with tamoxifen or with Imodium. Tamoxifen (Nolvadex®) is an anti-estrogen drug used to treat breast cancer. Loperamide (Imodium) is an over-the-counter medication used to prevent and treat diarrhea.
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

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

MLN0128 & Faslodex in Women with Advanced Breast Cancer Already Treated With an AI

An Open-Label Phase 2 Study of MLN0128 (A TORC1/2 Inhibitor) in Combination With Fulvestrant in Women With ER-Positive/HER2-Negative Advanced or Metastatic Breast Cancer That Has Progressed During or After Aromatase Inhibitor Therapy (NCT02756364)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer that is ER-positive and HER2-negative. You must also have already been treated with an aromatase inhibitor—letrozole (Femara), anastrozole (Arimidex) or exemestane (Aromasin). This study is comparing the safety and effect of a new drug called MLN0128 when it is given along with an anti-estrogen treatment. The new drug is a targeted treatment called MLN0128. It comes in pill form and is taken by mouth. The anti-estrogen drug is fulvestrant (Faslodex®). Given by injection, it is used to treat ER+ metastatic breast cancer in postmenopausal women who have already had other anti-estrogen treatments. In this study, some women will receive Faslodex alone, others will receive Faslodex and daily MLN0128, and others will receive Faslodex and weekly MNL0128.
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

Reversing Hormone Therapy Resistance in Metastatic Breast Cancer

Reversing Hormone Therapy Resistance With Epigenetic-immune Modification: Phase II Trial of Vorinostat, Tamoxifen and Pembrolizumab in Hormone Receptor Expressing Advanced Breast Cancer (NCT02395627)

Summary

This trial is looking at the best time to introduce the immunotherapy drug pembrolizumab (Keytruda®)—cycle 2 or cycle 4—to stage IV breast cancer patients started on a regimen of tamoxifen and vorinostat (Zolinza®). Keytruda is an immunotherapy drug that blocks a protein that keeps the immune system from going after cancer cells. It is approved for treating melanoma and non-small-cell lung cancer. Zolinza works by inhibiting a protein called histone deacetylase (HDAC). It is used to treat a type of lymphoma. Tamoxifen is an anti-estrogen therapy routinely used to treat early-stage and metastatic breast cancer. All participants will receive all three therapies. This is the first study to look at whether an immunotherapy can reduce hormone resistance in metastatic breast cancer. It is also the first study to look at the combination of Zolinza, tamoxifen and Keytruda in patients with ER+ advanced breast cancer who have already tried other hormone therapies.
This is a Phase II trial

Atezolizumab & Kadcyla or Atezolizumab, Herceptin & Perjeta in HER2-Positive Breast Cancer

A Phase Ib, Open-Label, Two-Arm Study Evaluating The Safety And Pharmacokinetics of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Trastuzumab Emtansine or With Trastuzumab And Pertuzumab in Patients With Her2 Positive Breast Cancer (NCT02605915)

Summary

Atezolizumab (MPDL3280A) is a new immunotherapy drug that blocks the programmed death 1 (PD-1) protein. Blocking the protein allows the immune system to kill cancer cells. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2-targeted therapies. Trastuzumab emtansine (Kadcyla®) combines the chemotherapy drug DM1 with Herceptin. This study is comparing the safety and effectiveness of atezolizumab, Herceptin and Perjeta to atezolizumab and Kadcyla in patients with HER2-positive metastatic breast cancer or with a HER2-positive primary tumor >2.0cm.
This is a Phase I trial

Mammaglobin-A DNA Vaccine + Hormone Therapy Before Surgery for ER+, HER2- Breast Cancer

A Phase 1B Randomized Clinical Trial to Evaluate the Safety and Immune Response to a Mammaglobin-A DNA Vaccine in Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy (NCT02204098)

Summary

Mammaglobin-A is a protein that is highly expressed by breast cancer cells. Laboratory studies suggest a mammaglobin-A DNA vaccine may trigger the body's immune system to destroy cancer cells. Hormone therapies are used to treat hormone-sensitive tumors. These medications include anastrozole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®), goserelin (Zoladex®) and tamoxifen. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study how the cancer responds to the treatment. This study is comparing the immune response seen in women with stage II or III ER-positive, HER2-negative breast cancer who receive a mammaglobin-A DNA vaccine along with hormone therapy or hormone therapy alone before surgery. The type of hormone therapy used will be chosen by the woman's oncologist. To be eligible for the study, a woman must have a breast tumor that expresses mammaglobin-A. In addition, participants must have a tumor Ki67 value of ≤ 10% after 14 days of neoadjuvant hormone therapy in order to be randomized to receive the Mammaglobin-A DNA vaccine.
This is a Phase I trial

Keytruda, Femara & Ibrance for ER+ Metastatic Breast Cancer After Femara & Ibrance

Phase II Study of the Addition of MK-3475 (Pembrolizumab) to Letrozole and Palbociclib in Patients With Metastatic Estrogen Receptor Positive Breast Cancer Who Have Stable Disease But Are Not Responding to Letrozole and Palbociclib (NCT02778685)

Summary

To take part in this study, you must have estrogen receptor-positive (ER+), HER2-negative, metastatic breast cancer. You must have also already been treated with letrozole (Femara®) and palbociclib (Ibrance®). Femara and Ibrance are an approved breast cancer combination. Femara is an anti-estrogen drug. Ibrance is a targeted treatment. Researchers think adding an immunotherapy drug to this combination will make the combination work better in women who already tried it. The immunotherapy drug that will be used in this study is pembrolizumab (Keytruda®). Keytruda is used to treat certain types of melanoma, lung cancer and head and neck cancers. It is available as a breast cancer treatment only in clinical trials.
This is a Phase II trial