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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 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

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

MCLA-128, Herceptin & Chemo or Hormone Therapy for HER2+ or ER+/Low HER2 Breast Cancer

Phase 2 Study of MCLA-128-based Combinations in Metastatic Breast Cancer (MBC): MCLA-128/Trastuzumab/Chemotherapy in HER2-positive MBC and MCLA-128/Endocrine Therapy in Estrogen Receptor Positive and Low HER2 Expression MBC (NCT03321981)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and a tumor that is HER2-positive or ER-positive with low HER2-expression. This study is evaluating the effects (good or bad) of an experimental immunotherapy drug called MCLA-128. If your tumor is HER2+, you will receive MCLA-128 along with the HER2-targeted drug trastuzumab (Herceptin®). If you are ER+, you will receive MCLA-128 along with the same endocrine therapy you received before entering the study: fulvestrant (Faslodex®), exemestane (Aromasin®), letrozole (Femara®) or anastrozole (Arimidex®). The chemotherapy drug used in this study is vinorelbine (Navelbine®).
This is a Phase II trial

G1T48 for Advanced ER+ HER2- Breast Cancer

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 in Women With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer (NCT03455270)

Summary

To take part in this study you must have ER positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer and have been treated with an aromatase inhibitor.

This study will evaluate the safety and effects (good and bad) of a using the hormonal therapy G1T48 to treat ER positive, HER2 negative advanced or metastatic breast cancer. G1T48 is type of hormone therapy called a selective estrogen receptor degrader (SERD).


This is a Phase I trial

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®).

Estradiol in Advanced Triple Negative Tumors that Test Positive for ER Beta

Therapeutic Targeting of ER Beta in Triple Negative Breast Cancer (NCT03941730)

Summary

To take part in this study you must be a woman with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer who has a tumor that tests positive for estrogen receptor beta (ER beta).

This study is investigating the effects (good and bad) of estradiol in the subset of triple negative tumors that test positive for ER beta. Early studies suggest that estradiol--a type of estrogen--slows the growth of tumors that are ER-beta positive.


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

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

H3B-6545 for Postmenopausal Women with ER+, HER2- Breast Cancer

A Phase I-II Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer (NCT03250676)

Summary

To take part in this study, you must be a postmenopausal woman who has ER+, HER2- advanced (some stage III) or metastatic (stage IV) breast cancer that progressed on your most recent therapy. This study will determine the best dose, safety, and effects (good and bad) of an experimental anti-estrogen drug called H3B-6545.
This is a Phase I-II trial

Lasofoxifene or Fulvestrant in ESR1 positive ER+/HER2− Advanced Breast Cancer

An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2− Breast Cancer With an ESR1 Mutation (NCT03781063)

Summary

To take part in this study you must be a postmenopausal woman with estrogen receptor positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer who has been treated with an aromatase inhibitor combined with a cyclin dependent kinase (CDK) 4/6 inhibitor, and has had a cell-free circulating tumor DNA (cDNA) test that shows your tumor has an ESR1 mutation.

This study is comparing the safety and effects (good and bad) of lasofoxifene (Fablyn®) with fulvestrant (Faslodex®). Fablyn is a nonsteroidal selective estrogen receptor modulator (SERM). It has been approved for use in other countries to treat osteoporosis, but is not approved in the U.S. Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.


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

Anti-Estrogen Treatment for Women 75 and Older at Low-Risk for Recurrence

Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score (NCT02476786)

Summary

To take part in this study, you must be age 75 or older and have been diagnosed with ER+, HER2- breast cancer that can be removed by surgery (stage I or stage II). Your tumor test must show that you have a slow-growing cancer and you must not yet have received any treatment for your cancer. This study will evaluate whether it is safe and effective to use anti-estrogen drugs alone to treat women age 75 and older. Your doctor will choose which anti-estrogen drug you receive: goserelin (Zoladex®), anastrozole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®), fulvestrant (Faslodex®), or tamoxifen (Nolvadex®). You will not have surgery, radiation, or chemotherapy unless your tumor starts to grow or you decide you want to have these treatments. Ki67 is a protein found in cancer cells. By measuring the amount of the protein in the cancer cells, researchers can learn how quickly the cancer cells are growing. To be in this study, you must have a slow-growing cancer, with a Ki67 score that is less than 10%.
This is a Phase II trial

Tamoxifen Delivered Through the Breast Skin to Control ER+ DCIS Before Surgery

Phase IIB Trial of Neoadjuvant Oral Tamoxifen Versus Transdermal 4-hydroxytamoxifen in Women With DCIS of the Breast (NCT02993159)

Summary

To take part in this study, you must have recently been diagnosed with ER+ DCIS and not yet had surgery. This study will compare the effect of tamoxifen (given orally) to an afimoxifene gel (applied to the breast before surgery) on the KI-67 protein in women with ER+ DCIS who are going to have surgery. The Ki-67 protein increases as the cell prepares to divide into new cells. Afimoxifene gel (TamoGel) is a topical anti-estrogen gel that is applied to the skin to relieve breast pain. Tamoxifen citrate (Nolvadex ®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer.
This is a Phase II trial

Hormone Therapy Before Surgery in HR-Positive HER2-Negative Breast Cancer Patients

Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive HER2-Negative Node-Negative Breast Cancer Patients to Assess Responses and Mechanisms of Endocrine Resistance (NCT03219476)

Summary

To take part in this study, you must have estrogen receptor positive, HER2 negative, node-negative breast cancer.

Researches are conducting this study to learn more about how breast tumors respond to different types of hormone therapies. Giving the hormone therapy before surgery (called neoadjuvant treatment) allows the researchers to study the effect it has on the cancer cells. There are four hormone therapies being used in this study. Three of them are aromatse inhibitors: anastrozole (Armidex®), letrozole (Femara®) and exemestane (Aromasin®). These hormone therapies are only used to treat postmenopausal women. The fourth hormone therapy is tamoxifen (Nolvadex ®). It is used to treat both pre-and postmenopausal women. Your doctor will decide which hormone therapy you should receive based on your medical history and menstrual status.


This is a Phase II trial

Fulvestrant plus Enzalutamide Before Surgery in AR+, ER+, HER2- Breast Cancer

Randomized Phase II Trial of Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer (NCT02955394)

Summary

To take part in this study, you must have been diagnosed with certain types of stage II and stage III, ER+, HER2- breast cancer. Your tumor most also be tested for and found to be androgen receptor positive (AR+). This study is investigating the safety and effects (good or bad) of giving an anti-estrogen drug along with an anti-androgen drug before surgery. Fulvestrant (Faslodex®) is the anti-estrogen drug being used in this study. It is approved to treat postmenopausal women with metastatic breast cancer. The anti-androgen drug used in this study is enzalutamide (Xtandi®). It is currently used to treat prostate cancer. If you are pre- or peri- menopausal, you will also receive a drug to shut down your ovaries.
This is a Phase II trial

RAD140 for Postmenopausal Women With HR+ Advanced Breast Cancer

A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer (NCT03088527)

Summary

To take part in this study, you must be postmenopausal and have HR-positive advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety, best dose, and effects (good or bad) of an investigational hormone therapy called RAD140 in patients whose tumors are no longer responding to standard treatme


This is a Phase I trial

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

D-0502 Alone or in Combination With Ibrance in ER+, HER2- Advanced Breast Cancer

A Phase I, Open-Label Study of D-0502 Single Agent and D-0502 in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer (NCT03471663)

Summary

To take part in this study, you must have ER positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety, effects (good and bad) and best dose of an experimental anti-estrogen therapy when it is given alone or in combination with palbociclib (Ibrance®). D-0502 is the experimental anti-estrogen therapy used in this study. Ibrance®) is approved to treat hormone sensitive, HER2 negative breast cancer in combination with an anti-estrogen therapy in postmenopausal women. If you are premenopausal, you will also be given a therapy that will stop your ovaries from producing estrogen.


This is a Phase I trial

TAK-228 and Letrozole in Postmenopausal Women With High-Risk ER+ and HER2-Low Breast Cancer

Phase 1b Neoadjuvant Run-In Study With TAK-228 Followed by Letrozole/TAK-228 in Women With High-Risk ER+/HER2- Breast Cancer (NCT02619669)

Summary

To take part in this study you must be a postmenopausal woman with stage I, stage II, stage III or metastatic (stage IV) breast cancer that is estrogen receptor (ER) positive and low HER2 (defined as IHC 0-1+) and has a high risk for recurrence. This study is investigating the safety and effects (good or bad) of the combination of TAK-228 and letrozole (Femara®) when given before surgery. This is called neoadjuvant treatment. TAK-228 is a new type of targeted therapy called a TORC inhibitor. Femara® is a type of hormone therapy called an aromatase inhibitor. It is approved to treat postmenopausal women with breast cancer.
This is a Phase I trial

Faslodex, Ibrance & Erdafitinib for ER+, HER2-, Advanced Breast Cancer

A Phase Ib Trial of Fulvestrant, Palbociclib (CDK4/6 Inhibitor) and Erdafitinib (JNJ- 42756493,Pan-FGFR Tyrosine Kinase Inhibitor) in ER+/HER2-/FGFR-Amplified Metastatic Breast Cancer (MBC) (NCT03238196)

Summary

To take part in this study, you must have ER+, HER2- metastatic (stage IV) breast cancer. Your tumor will be tested to see if it is FGFR-amplified. It must be FGFR-amplified for you to take part in this study. This study is investigating the best dose, safety and effects (good or bad) of giving targeted therapies along with hormone therapy. Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. Erdafitinib (JNJ-42756493) is an experimental targeted therapy that works by targeting the FGFR tyrosine kinase protein. Fulvestrant (Faslodex®) is the hormone therapy used in this study. It is approved to treat metastatic breast cancer.
This is a Phase I trial

Alpelisib & Enzalutamide in Advanced Breast Cancer That Tests AR+ and PTEN+

Phase Ib Study of BYL719 (Alpelisib) in Combination With Androgen Receptor Inhibitor (Enzalutamide) in Patients With Androgen Receptor (AR)-Positive and PTEN Positive Metastatic Breast Cancer (NCT03207529)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER positive and/or PR positive) or triple negative (ER-, PR-, HER2-) breast cancer that tests AR-positive and PTEN-positive and has been treated with at least one standard therapy.

This study will investigate the best dose, safety, and effects (good and bad) of alpelisib (Piqray®) when it is used along with enzalutamide (Xtandi®). Piqray is a targeted therapy that inhibits PI3K. It is approved to treat advanced hormone receptor positive, HER2 negative breast cancer in patients with a tumor that has a PIK3CA mutation. Xtandi is an oral drug that targets the androgen receptor (AR). It is approved to treat advanced prostate cancer.


This is a Phase I trial

Elacestrant for ER+ and HER2- Advanced Breast Cancer (EMERALD)

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial (NCT03778931)

Summary

To take part in this study you must have locally advanced (some stage III) or metastatic (stage IV) breast cancer that is ER positive and HER2 negative and you must have already been treated with a CDK4/6 inhibitor in combination with fulvestrant (Faslodex) or an aromatase inhibitor.

This study is comparing the effects (good and bad) of elacestrant to fulvestrant (Faslodex) or an aromatase inhibitor. Elacestrant is an investigational hormone therapy. It is expected to work in a similar way to fulvestrant, but is given once a day my mouth rather than by monthly injections. The study will also look at the effectiveness of elacestrant compared to other drugs in women and men with ER-positive breast cancer including those whose tumors have mutations in the ESR1 gene. Faslodex and aromatase inhibitors are used to treat metastatic breast cancer.


This is a Phase III trial

Ibrance & Casodex for Metastatic Triple Negative Breast Cancer with Androgen Receptors

Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) (NCT02605486)

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. Bicalutamide (Casodex®) is an anti-androgen drug used to treat prostate cancer. Some breast cancers contain androgen receptors. Laboratory studies suggest these tumors may respond to anti-androgen treatment. This study is testing the safety and effectiveness of using Ibrance and Casodex to treat triple negative breast cancer that is androgen receptor positive. To be eligible for this trial, participants must have triple negative, androgen receptor positive, metastatic breast cancer.


This is a Phase I-II trial

Ribociclib with Hormone Therapy for ER+ Early Stage Breast Cancer

Phase II Study of CDK 4/6 Inhibitor, LEE011 (Ribociclib), in Combination With Adjuvant Endocrine Therapy at Varying Duration for ER-positive Breast Cancer (LEADER) (NCT03285412)

Summary

To take part in this study, you must have ER-positive, early stage (stage I-III) breast cancer.

In this study, researchers will compare the safety and effects (good and bad) of two different doses of the targeted drug ribociclib (Kisqali®) that will be given on two different schedules along with a hormone therapy. Kisqali 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. It is FDA approved for use along with an aromatase inhibitor to treat advanced breast cancer. The hormone therapy you receive will be chosen by the physician leading the study.


This is a Phase II trial

Xentuzumab With Everolimus and Exemestane in HR Positive and HER2 Negative Advanced Breast Cancer

XENERA™-1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Post-menopausal Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease (NCT03659136)

Summary

To take part in this study you must be a postmenopausal woman with HR positive HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is to comparing the effect (good or bad) of the combination of xentuzamab, everolimus (Afinitor®), and exemestane (Aromasin®) to the combination of a placebo, Afinitor and Aromasin. Xentuzumab is an investigational targeted therapy that blocks insulin-like growth factor (IGF). Studies suggest it may improve how cancer cells respond to chemotherapy. Aromasin is an anti-estrogen drug used to treat breast cancer. Afinitor is a chemotherapy drug used to treat advanced HR positive HER2 negative breast cancer.


This is a Phase II trial

Ibrance plus Femara or Faslodex for HR+, HER2- Metastatic Breast Cancer

A Phase II Clinical Trial Assessing the Safety of an Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer (NCT03007979)

Summary

To take part in this study, you must have HR-positive (ER+/PR+), HER2-negative metastatic (stage IV) breast cancer. This study is evaluating a new dosing schedule for the targeted drug palbociclib (Ibrance®). If you are in this study you will receive Ibrance® for 5 days on with 2 days off, instead of the current standard schedule of 3 weeks on and 1 week off. You will also receive the anti-estrogen drugs letrozole (Femara®) and fulvestrant (Faslodex®). If you are premenopausal, you will receive a drug to shut down your ovaries.
This is a Phase II trial

A New Three-Drug Combination for HR+, HER2- Metastatic Breast Cancer

A Phase 1b/2a Study Of Palbociclib In Combination With Everolimus And Exemestane In Postmenopausal Women With Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer (NCT02871791)

Summary

To take part in this study, you must have hormone sensitive (ER+ and/or PR+), HER2-negative metastatic breast cancer. Researchers think using three drugs that work in different ways will be an effective breast cancer treatment. The three drugs patients who enroll in this study will receive are palbociclib (Ibrance®), everolimus (Afinitor®) and exemestane (Aromasin®). The researchers will determine the best dose of each drug to use when the three drugs are given together. All three drugs are used to treat metastatic breast cancer. It is not known how well they work when given together. Ibrance is a targeted drug that blocks two proteins, CDK 4 and CDK 6. Afinitor is a targeted drug that blocks mTOR. Aromasin is an anti-estrogen drug.
This is a Phase I-II trial

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

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

Summary

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

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

Xentuzumab & Abemaciclib & an Anti-Estrogen Drug for Advanced Breast Cancer

An Open Label, Phase Ib Dose-escalation Study Evaluating the Safety and Tolerability of BI 836845 and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumors and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive Breast Cancer, Followed by Expansion Cohorts (NCT03099174)

Summary

To take part in this study, you must have HR-positive (ER+/PR+), HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. This study will identify the best dose, safety and effectiveness for two new targeted drugs. The drugs will be given along with an anti-estrogen drug. The two new targeted drugs are xentuzumab (BI 836845) and abemaciclib (LY2835219). The anti-estrogen drug you are given will be letrozole (Femara®), anastrozole (Arimidex®) or fulvestrant (Faslodex®).
This is a Phase I trial

Ibrance and Bosutinib With Fulvestrant in Patients With Metastatic HR+ HER2- Breast Cancer Refractory to an Aromatase Inhibitor and a CDK4/6 Inhibitor

A Phase I Trial of Palbociclib and Bosutinib With Fulvestrant in Patients With Metastatic Hormone Receptor Positive and HER2 Negative (HR+ HER2-) Breast Cancer Refractory to an Aromatase Inhibitor and a CDK4/6 Inhibitor (NCT03854903)

Summary

To take part in this study you must be a woman with estrogen receptor positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer, have had no more than 3 chemotherapy regimens, and have been treated with at least one aromatase inhibitor and one CDK 4/6 inhibitor.

This trial is evaluating the safety, best dose and effects (good and bad) of bosutinib (Bosulif®) when it is used along with palbociclib (Ibrance®) and fulvestrant (Faslodex®). Bosulif is a targeted therapy approved to treat certain types of leukemia. Its use in breast cancer is considered experimental. Ibrance is a targeted therapy approved to treat metastatic breast cancer in combination with Faslodex or letrozole (Femara®), which are both hormone therapies.


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

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

Ibrance, Bavencio and Faslodex for Previously Treated ER+, HER2- Advanced Breast Cancer

Palbociclib After CDK and Endocrine Therapy (PACE): A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer (NCT03147287)

Summary

To take part in this study, you must have HR+, HER2-negative locally recurrent (some stage III) or metastatic (stage IV) breast cancer. You must have already been treated with a CDK4/6 inhibitor in combination with an anti-estrogen therapy. This study is investigating the safety and effects (good and bad) of using fulvestrant (Faslodex®) alone, in combination with Ibrance®, and in combination with Ibrance and Bavencio®. Faslodex is the anti-estrogen drug used in this study. Palbociclib (Ibrance®) is approved to treat HR+, HER2-negative breast cancer in combination with an anti-estrogen therapy. Avelumab (Bavencio®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat a type of blood cancer.
This is a Phase II trial

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

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

Summary

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

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

Targeted and Hormone Therapies plus Ibrance for HER2+, HR+ Metastatic Breast Cancer

A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer (PATINA) (NCT02947685)

Summary

To take part in this study, you must have HER2-positive, HR-positive (ER+/PR+) advanced (some stage III) or metastatic (stage IV) breast cancer. You must have already had at least 4 and at most 8 cycles of a HER2-targeted drug. This study is comparing the safety and effects (good and bad) of using a targeted drug along with the standard of care for treating HER2+, HR+ advanced breast cancer to the standard of care alone. The standard of care is a HER2-targeted drug and an anti-estrogen drug. The targeted drug being used in this study is palbociclib (Ibrance®). It is approved for treating metastatic breast cancer.
This is a Phase III trial

LSZ102 Alone or With Ribociclib or Alpelisib in ER+ Advanced Breast Cancer

A Phase I/Ib, Open Label Study of LSZ102 Single Agent and LSZ102 in Combination With Either LEE011 (LSZ102 + LEE011) or BYL719 (LSZ102 + BYL719) in Patients With Advanced or Metastatic ER+ Breast Cancer Who Have Progressed After Endocrine Therapy (NCT02734615)

Summary

Researchers are developing new drugs to treat hormone-sensitive metastatic breast cancer. LSZ102 is a new drug that works by destroying the estrogen receptor. In this study, researchers will determine the best dose of LSZ102 to give alone or in combination with a targeted drug. The two targeted drugs are called ribociclib and alpelisib. To take part in this study, you must have ER+ advanced or metastatic breast cancer and already have been treated with hormone therapy.
This is a Phase I 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

Faslodex and Xtandi for ER+, HER2- Metastatic Breast Cancer

Phase II Trial of Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer (NCT02953860)

Summary

To take part in this study, you must have ER-positive, HER2-negative metastatic (stage IV) breast cancer. Your tumor must also be androgen receptor positive (AR+). This tumor test will be done by the researchers. This study is investigating the the safety and effects (good and bad) of using an anti-estrogen drug and an anti-androgen drug to treat ER+, HER2- metastatic breast cancer. The anti-estrogen drug used in this study is fulvestrant (Faslodex®). It is approved to treat postmenopausal women with metastatic breast cancer. The anti-androgen drug is enzalutamide (Xtandi®). It is approved to treat prostate cancer. If you are premenopausal, you will also receive a drug to shut down your ovaries.
This is a Phase II trial

Palbociclib With Fulvestrant for ER+, HER2- Advanced Breast Cancer

Phase II Trial of Palbociclib With Fulvestrant in Individuals With Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Who Have Progressed on Treatment With Palbociclib and an Aromatase Inhibitor (NCT02738866)

Summary

To take part in this study you must have ER positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer and have already been treated with palbociclib (Ibrance®) and an aromatase inhibitor.

This trial is investigating the safety and effects (good and bad) of using Ibrance and Faslodex to treat women and men with advanced breast cancer who have previously been treated with Ibrance and an aromatase inhibitor. Ibrance is a CDK4/6 inhibitor approved to treat HR positive, HER2 negative breast cancer in combination with an anti-estrogen therapy. Faslodex is an anti-estrogen therapy approved to treat postmenopausal women with metastatic breast cancer.


This is a Phase II trial

Arimidex, Ibrance, Herceptin and Perjeta for HR+, HER2+ Metastatic Breast Cancer

A Multicenter, Phase I/II Trial of Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HeR-positive, Her2-positive Metastatic Breast Cancer (NCT03304080)

Summary

To take part in this study, you must have HR+ (ER+/PR+), HER2+ metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using two anti-estrogen targeted therapies and two HER2-targeted therapies to treat HR+, HER2+ metastatic breast cancer. The anti-estrogen therapies being used in this study are palbociclib (Ibrance®) and anastrozole (Arimidex®). The HER2-targeted therapies are trastuzumab (Herceptin®) and pertuzumab (Perjeta®). All four therapies are approved to treat metastatic breast cancer.
This is a Phase I-II trial

GDC-0077 & Hormone Therapy with or without Ibrance for Advanced Breast Cancer

A Phase I, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0077 as a Single Agent in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Solid Tumors and in Combination With Endocrine and Targeted Therapies in Patients With Locally Advanced or Metastatic PIK3CA-Mutant... (NCT03006172)

Summary

To take part in this study, you must have advanced breast cancer (metastatic/stage IV and some stage III) that has a PIK3CA mutation. (Your tumor will be tested for a PIK3CA mutation to see if you are eligible.) This study is investigating the safety and effect of a new drug called GDC-0077 when it is used to treat advanced breast cancer that has a PIK3CA mutation. If your tumor is hormone-sensitive (ER+ and/or PR+) and HER2-negative you will receive GDC-0077 with a targeted drug and/or an anti-estrogen drug. Palbociclib (Ibrance®) is the targeted drug being used in this study. Letrozole (Femara®) and fulvestrant (Faslodex®) are the anti-estrogen drugs. All are approved breast cancer treatments.
This is a Phase I trial

Ibrance with Femara and Herceptin Before Surgery for Stage II-III ER+ HER2+ Breast Cancer

A Phase II Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab as Neoadjuvant Treatment of Stage II-III ER+ HER2+ Breast Cancer (PALTAN) (NCT02907918)

Summary

To take part in this study, you must have been diagnosed with ER-positive, HER2-positive stage II-III breast cancer and not yet started treatment. This study is investigating the effect that a combination therapy used to treat HER2-negative breast cancer has on ER+, HER2+ breast cancer cells when it is given along with a HER2-targeted drug. The effect of the treatment will be studied by giving the therapy before surgery. This is called neoadjuvant treatment. The three drugs that will be used in this study are the targeted drug palbocicilib (Ibrance®), which is used along with an anti-estrogen drug to treat metastatic ER+, HER2- breast cancer; the anti-estrogen drug letrozole (Femara®); and the HER2-targeted drug trastuzumab (Herceptin®). If you are premenopausal, you will also receive a drug to shut down your ovaries.
This is a Phase II trial

Tucatinib, Ibrance plus Femara in Advanced HR+, HER2+ Breast Cancer

Phase IB/II Open-label Single Arm Study to Evaluate Safety and Efficacy of Tucatinib in Combination With Palbociclib and Letrozole in Subjects With Hormone Receptor Positive and HER2-positive Metastatic Breast Cancer (NCT03054363)

Summary

To take part in this study, you must have hormone receptor-positive (ER+ and/or PR+), HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer. This must be your first or second treatment for your advanced cancer. This study is investigating the safety and effects (good or bad) of using two targeted therapies along with a hormone therapy to treat advanced HR+, HER2+ breast cancer. The two targeted therapies being used in this study are tucatinib (ONT-380) and palbociclib (Ibrance®). Tucatinib is a tyrosine kinase inhibitor that targets HER2. Ibrance targets the CDK 4/6 protein and is approved by the FDA to treat postmenopausal women with ER+, HER2+ metastatic breast cancer. The hormone therapy used in this study is letrozole (Femara®). Premenopausal women who enroll in this study will also receive a drug to stop ovarian function.
This is a Phase I-II trial

AZD9833 With or Without Palbociclib in ER Positive and HER2 Negative Advanced Breast Cancer

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination With Palbociclib in Women With ER Positive, HER2 Negative Advanced Breast Cancer(NCT03616587)

Summary

To take part in this study, you must have ER positive and HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer that did not respond to standard therapies and, if metastatic, has not been treated with more than two different chemotherapy regimens.

This study will evaluate the safety and effect (good or bad) of AZD9833 alone or in combination with palbociclib (Ibrance®). AZD9833 is an experimental drug that targets the estrogen receptor and is being developed to treat ER positive, HER2 negative breast cancer. Ibrance is a targeted drug used to treat metastatic breast cancer. If you are premenopausal, you will also receive a drug that will put you in temporary menopause.


This is a Phase I trial

Seribantumab Plus Faslodex for Postmenopausal Women With HR+ Advanced Breast Cancer

SHERBOC: A Double-blind, Placebo-controlled, Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer (NCT03241810)

Summary

To take part in this study, you must be postmenopausal and have advanced (stage III) or metastatic (stage IV) breast cancer. You must have had no more than two prior therapies, one of which was a CDK inhibitor. This study is comparing the safety and effects (good and bad) of giving an anti-estrogen drug along with a new targeted therapy to giving an anti-estrogen drug along with a placebo in postmenopausal women with advanced breast cancer. The anti-estrogen drug being used in this study is fulvestrant (Faslodex®). It is commonly used to treat advanced breast cancer. The targeted therapy being used in this study is called seribantumab (MM-121).


This is a Phase II trial

Tamoxifen, Palbociclib, Avelumab Before Surgery in ER Positive Breast Cancer

A Pilot Study of IMMUNe mOdulation in Early Stage Estrogen Receptor Positive Breast Cancer Treated With neoADjuvant Avelumab, Palbociclib, and Tamoxifen: The ImmunoADAPT Study (NCT03573648)

Summary

To take part in this study you must have stage II or stage III ER-positive breast cancer that will be treated with surgery.

This study is investigating whether giving tamoxifen and avelumab before surgery shrinks tumors more than the combination of tamoxifen, avelumab and palbociclib. Tamoxifen (Nolvadex®) is a hormonal therapy used to treat ER-positive breast cancer. Avelumab (Bavencio®) is a type of immunotherapy drug called a PD-L1 inhibitor. It is approved to treat non-small-cell lung cancer. Its use in breast cancer is considered experimental. Palbociclib (Ibrance®) is a CDK inhibitor. It is approved to treat ER-positive, HER2-negative metastatic breast cancer. Giving therapies before surgery, called neoadjuvant treatment, allows researchers to measure how tumors respond to different therapies.


This is a Phase II trial

Alisertib plus Fulvestrant for Advanced ER+, HER2- Breast Cancer

Randomized Phase II Trial to Evaluate Alisertib Alone or Combined With Fulvestrant for Women With Advanced, Endocrine-Resistant Breast Cancer (NCT02860000)

Summary

To take part in this study, you must be postmenopausal and have ER-positive, HER2-negative locally advanced (some stage III) or metastatic (stage IV) breast cancer. You must not have been treated with an aurora kinase inhibitor. This study is comparing the safety and effect of the targeted drug alisertib alone to the combination of alisertib and fulvestrant (Faslodex®) in postmenopausal women with locally advanced or metastatic breast cancer. Alisertib is an experimental targeted drug that blocks aurora A kinase. Faslodex is an anti-estrogen drug used to treat hormone-sensitive metastatic breast cancer in postmenopausal women.


This is a Phase II trial

Radiation Therapy, Palbociclib & Hormone Therapy for Breast Cancer Related Bone Metastases

A Phase II Multi-Institutional Study of Concurrent Radiotherapy, Palbociclib, and Hormone Therapy for Treatment of Bone Metastasis in Breast Cancer Patients (NCT03691493)

Summary

To take part in this study you must have estrogen receptor positive, HER2 negative metastatic (stage IV) breast cancer that has spread to the bone.

This study will investigate the effects (good or bad) of using radiation therapy along with the targeted therapy palbociclib (Ibrance®) and hormone therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Ibrance is a type of targeted therapy called a CDK 4/6 inhibitor. It is used along with a hormone therapy to treat metastatic breast cancer. The hormone therapies used along with Ibrance are fulvestrant (Faslodex®), letrozole (Femara®), anastrozole (Arimidex®), exemestane (Aromasin®) and tamoxifen.


This is a Phase II trial

Neratinib plus Faslodex for HER2+, ER+ Advanced Breast Cancer

A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer (NCT03289039)

Summary

To take part in this study, you must have ER-positive, HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using a newly approved targeted therapy along with a hormone therapy to treat advanced breast cancer. The newly approved targeted therapy is neratinib (Nerlynx®). It is a tyrosine kinase inhibitor that is approved to treat early-stage HER2+ breast cancer. Fulvestrant (Faslodex®) is a hormone therapy approved to treat hormone sensitive metastatic breast cancer in postmenopausal women.
This is a Phase II trial

SAR439859 with Ibrance in Postmenopausal Women with ER+, HER2- Advanced Breast Cancer

A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy, Then in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer(NCT03284957)

Summary

To take part in this study, you must have ER-positive, HER2-negative, locally advanced (some stage III) or metastatic (stage IV) breast cancer. You must also be postmenopausal and have already received treatment for your breast cancer. This study will determine the best dose, safety and effects (good or bad) of SAR439859 when it is given alone or in combination with palbociclib (Ibrance®). SAR439859 is an experimental anti-estrogen drug. It is available only in clinical trials. Ibrance® is a targeted therapy that blocks the CDK4/6 protein. It is approved to treat postmenopausal women with ER+, HER2- metastatic breast cancer.
This is a Phase I-II trial

Ibrance, Ovarian Suppression & Letrozole Before Surgery in Premenopausal Breast Cancer

An Assessment of the Biological and Clinical Effects of Palbociclib (PD 0332991) With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Patients With Premenopausal Estrogen-Receptor Positive/HER2-Negative Primary Breast Cancer (NCT03628066)

Summary

To take part in this study you must be premenopausal, have estrogen receptor positive HER2 negative stage II or stage III breast cancer, had your tumor score less than 26 on the OncotypeDX test, and not yet had surgery.

This study will look at the safety and effects (good and bad) of giving palbociclib (Ibrance®) and a hormone therapy before surgery to premenopausal women. Ibrance is a type of targeted drug called a CDK inhibitor. It is given along with hormone therapy--either letrozole (Femara®) or fulvestrant (Faslodex®)--to treat breast cancer in postmenopausal women. To study the combination in premenopausal women, patients will be given goserelin (Zoladex®), a drug that shuts down the ovaries.


This is a Phase II trial

Fulvestrant and Venetoclax for ER+, HER2- Advanced Breast Cancer

A Phase II, Multicenter, Randomized Study To Compare The Efficacy Of Venetoclax Plus Fulvestrant Versus Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy (NCT03584009)

Summary

To take part in this study you must be a woman with estrogen receptor positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer who has already been treated with a CDK 4/6 inhibitor.

This study is comparing the effects of fulvestrant (Faslodex) and ventoclax to fulvestrant alone in women with advanced estrogen receptor positive, HER2 negative breast cancer who have already been treated with a CDK 4/6 inhibitor. Faslodex is an anti-estrogen therapy used to treat advanced breast cancer. Venetoclax (Venclexta) is targeted therapy approved to treat certain types of blood cancers.


This is a Phase II trial

Hydroxychloroquin, Palbociclib & Letrozole for ER+ HER2- Breast Cancer

Phase I/II Safety and Efficacy Study of Autophagy Inhibition With Hydroxychloroquine to Augment the Antiproliferative and Biological Effects of Pre-Operative Palbociclib Plus Letrozole for Estrogen Receptor-Positive and HER2-Negative Breast Cancer (NCT03774472)

Summary

To take part in this study you must be a postmenopausal woman with HR positive and HER2 negative breast cancer who has not yet had surgery (if you have an early-stage breast cancer) and has not been treated with a CDK 4/6 inhibitor (if you have metastatic breast cancer).

This study is investigating the safety, best dose and effects (good and bad) of giving hydroxychloroquine along with palbociclib (Ibrance®) and letrozole (Femara®). Hydroxychloroquine is a drug that decreases immune responses in the body. It is routinely used to prevent or to treat malaria and some auto-immune diseases. Ibrance is a targeted drug that is given along with hormone therapy to treat metastatic breast cancer in postmenopausal women. Femara is an aromatase inhibitor used to treat early-stage and metastatic breast cancer in postmenopausal women. It is approved for use along with Ibrance.


This is a Phase I-II trial

GSK525762 plus Faslodex for ER+ Advanced Breast Cancer

A Phase I/II Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Fulvestrant in Subjects With ER+ Breast Cancer (NCT02964507)

Summary

To take part in this study, you must have ER+ advanced (some stage III) or metastatic (stage IV) breast cancer. GSK525762 is a newly developed drug that researchers think may be effective for treating ER+ advanced breast cancer. This study will determine whether it is safe to treat breast cancer with GSK525762. It will also identify the best dose of GSK525762 to use when it is given with fulvestrant (Faslodex®), an anti-estrogen drug commonly used to treat advanced breast cancer.
This is a Phase II trial

Alpelisib plus Endocrine Therapy for HR+, HER2- Advanced Breast Cancer

A Phase II, Multicenter, Open-label, Two-cohort, Non-comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After CDK 4/6 Inhibitor Treatment (NCT03056755)

Summary

To take part in this study, you must have HR-positive (ER+/PR+), HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. Your tumor must also test positive for a PIK3CA mutation. In addition, you must already have been treated with a CDK4/6 inhibitor. This study is investigating the safety and effects (good and bad) of giving the targeted drug alpelisib along with an anti-estrogen drug to women with HR+, HER2- advanced breast cancer already treated with a CDK4/6 inhibitor. Alpelisib (BYL719) is a PI3K inhibitor. Fulvestrant (Faslodex®) or letrozole (Femara®) are the anti-estrogen drugs used in this study. The anti-estrogen drug you receive will be based on the anti-estrogen drug you received when on the CDK4/6 inhibitor.
This is a Phase II trial

Ipatasertib, Hormone Therapy and Ibrance for Metastatic Breast Cancer (TAKTIC)

Clinical Trial to Evaluate Safety and Anti-tumor Activity of AKT Inhibitor, Ipatasertib,With Endocrine Therapy With/Without CDK 4/6 Inhibitor for Patients With Metastatic Hormone Receptor Positive Breast Cancer (TAKTIC)(NCT03959891)

Summary

To take part in this study you must be a postmenopausal woman with estrogen receptor positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on at least one therapy.

This trial is investigating the safety and effects (good and bad) of combining ipatasertib with palbociclib (Ibrance®) and/or a hormone therapy. Ipatasertib is an investigational targeted therapy that blocks AKT (protein kinase B). Ibrance is a CDK4/6 inhibitor approved to treat HR positive, HER2 negative breast cancer in combination with an anti-estrogen therapy. The two hormone therapies used in this study are fulvestrant (Faslodex®) and letrozole (Femara®). Both are routinely used to treat breast cancer.


This is a Phase I 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

Ibrance and Hormone Therapy for Adults Age 70 & Older with ER+, HER2- Metastatic Breast Cancer

A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer (NCT03633331)

Summary

To take part in this study, you must be 70 or older and have ER positive HER2 negative metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of giving the targeted therapy palbociclib (Ibrance®) along with a hormone therapy in women and men age 70 or older. Ibrance is approved to treat metastatic breast cancer in combination with a type of hormone therapy called an aromatase inhibitor. The two aromatase inhibitors being used in this trial are letrozole (Femara®) and fulvestrant (Faslodex®).


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. 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

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

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

A Phase II Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients: Big Ten Cancer Research Consortium BTCRC-BRE16-042 (NCT03393845)

Summary

To take part in this study, you must have HR-positive, HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using pembrolizumab (Keytruda®) along with fulvestrant (Faslodex®) to treat HR+, HER2- advanced breast cancer. Keytruda is type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers, but not breast cancer. Faslodex is a hormone therapy that is used to treat hormone sensitive breast cancer in postmenopausal women.
This is a Phase II trial

Nivolumab Combined with Ipilimumab and Bicalutamide for HER2 Negative Advanced Breast Cancer

A Phase II Study of Nivolumab Combined With Bicalutamide and Ipilimumab in Metastatic HER2-negative Breast Cancer (NCT03650894)

Summary

To take part in this study you must be a woman with HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is testing the safety and effects (good or bad) of using a combination of nivolumab (Opdivo®), ipilimumab (Yervoy®), and bicalutamide (Casodex®). Opdivo® is a type of immunotherapy that gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). Yervoy is an immunotherapy that works by blocking a protein called CTLA-4. Yervoy and Opdivo are approved to be used together to treat patients with melanoma and certain other cancers. Their use in breast cancer is considered experimental. Casodex is an anti-androgen drug used to treat prostate cancer. Some breast cancers contain androgen receptors. Laboratory studies suggest these tumors may respond to anti-androgen therapies.


This is a Phase II 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 plus an Anti-Estrogen Drug for HR+ Inflammatory Breast Cancer

A Phase II Study of Anti-PD-1 (Pembrolizumab) in Combination With Hormonal Therapy in Patients With Hormone Receptor (HR)-Positive Localized Inflammatory Breast Cancer (IBC) Who Did Not Achieve a Pathological Complete Response (pCR) to Neoadjuvant Chemotherapy (NCT02971748)

Summary

To take part in this study, you must have hormone-sensitive (ER+/PR+) inflammatory breast cancer. In addition, your tumor must have not completely responded to the chemotherapy you received before surgery. This study is looking at whether it is safe and effective to treat patients with inflammatory breast cancer with an immunotherapy drug along with a standard anti-estrogen drug. The immunotherapy drug being used in this study is pembrolizumab (Keytruda®). Your doctor will choose which anti-estrogen drug you receive: tamoxifen/Nolvadex®, exemestane/Aromasin®, anastorzole/Arimidex®, or letrozole/Femara®. If you are premenopausal, you may also receive an LHRH (lutenizing hormone-releasing hormone) agonist.
This is a Phase II trial

Adherence to Aromatase Inhibitors in HR+ Stage I-III Latina & Other Breast Cancer Patients

Adherence of Hispanic / Latina Breast Cancer - Patients to Adjuvant Aromatase Inhibitors - (AIs) (NCT03144037)

Summary

To take part in this study, you must be a postmenopausal women who is taking an aromatase inhibitor (AI) after surgery to treat HR+ (ER+/PR+) stage I-III breast cancer. This study will help researchers learn more about how well women on AI hormone therapy adhere to their treatment regimen. The researchers are making an effort to recruit Latinas who are being treated at Texas Tech University Health Sciences Center in El Paso for this study, but women of all ethnic groups can take part.

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.