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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+).

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

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

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

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.

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

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

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

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

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

Aromasin Before Surgery for Postmenopausal Women with ER+ DCIS or Stage I-II Breast Cancer

Alternative Dosing of Exemestane in Postmenopausal Women With Stage 0-II ER-Positive Breast Cancer: A Randomized Presurgical Trial (NCT02598557)

Summary

To take part in this study, you must be postmenopausal and have ER+ DCIS or stage I-II breast cancer and have not yet had surgery. This study is evaluating the effectiveness of and side effects associated with three different doses of an anti-estrogen drug given before surgery to treat ER+ DCIS or stage I-II breast cancer. The drug being studied is the aromatase inhibitor exemestane (Aromasin®). Giving the drug before surgery can shrink the tumor. It also allows the researchers to study the effect the drug has on the cancer cells.
This is a Phase II 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

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

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

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 a hormone 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

Aromatase Inhibitor and Perjeta and Herceptin Before Surgery for Stage I-II Breast Cancer

A Phase II Study of NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) (NCT02689921)

Summary

To take part in this study, you must have been diagnosed with stage I or stage II breast cancer that is hormone sensitive (ER+ and/or PR+) and HER2+. You must not yet have received any treatment. This study is looking at using a chemo-free approach for treating early stage, hormone sensitive, HER2+ breast cancer. It will look at the safety and effectiveness of using two HER2-targeted drugs and an aromatase inhibitor before surgery. The HER2-targeted drugs being used in this study are pertuzumab (Perjeta®) and trastuzumab (Herceptin®). Your doctor will choose which aromatase inhibitor you receive: exemestane/Aromasin®, letrozole/Femara®, or anastrozole/Arimidex®. All of these drugs are approved breast cancer treatments. For more information, contact: 847-7872-4701.
This is a Phase II 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

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

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

TAK-228 plus Tamoxifen Before Surgery for ER+, HER2- Stage II-III Breast Cancer

Open Label, Phase II Trial of Neoadjuvant TAK-228 Plus Tamoxifen in Patients With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (NCT02988986)

Summary

To take part in this study, you must have recently been diagnosed with HR-positive (ER+/PR+), HER2-negative stage II or III breast cancer. This study will help researchers learn more about the safety and effects (good and bad) of giving a new targeted drug along with tamoxifen before surgery. The targeted drug is an mTOR inhibitor called TAK-228. Tamoxifen (Nolvadex®) is a hormone therapy used to treat hormone-sensitive breast cancer. Studies suggest that targeting the mTOR pathway will keep tumors responding to tamoxifen for a longer period of time.
This is a Phase II trial

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

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

Summary

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

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

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

Ribociclib with Letrozole for HR+, HER2- Advanced Breast Cancer

COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) with no prior Hormonal Therapy for Adv Disease (NCT02941926)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) HER2-negative breast cancer. You must also not have been treated with a CDK4/6 inhibitor. If you have advanced breast cancer, you must not have been treated with an anti-estrogen drug. If you have metastatic breast cancer, you must not have had more than one prior regimen of chemotherapy. This study is investigating the safety and effectiveness of treating advanced and metastatic breast cancer with a targeted drug and an anti-estrogen drug. The targeted drug being used in this study is ribociclib (LEE011). It is a CDK4/6 inhibitor. The anti-estrogen drug being used in this study is letrozole (Femara®). It is approved to treat breast cancer in postmenopausal women. If you are male or premenopausal, you will also be treated with goserelin (Zoladex®).
This is a Phase III trial

GDC-0032 For Advanced Breast Cancer

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

Summary

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

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 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

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

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

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

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 (E2112) (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

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 ant-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

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

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

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

Ribociclib plus Hormone Therapy after Surgery for HR+, HER2- Early Stage Breast Cancer

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer (NCT03078751)

Summary

To take part in this study, you must have HR-positive (ER+/PR+), HER2-negative early stage (stage I-III) breast cancer. You must also have had multi-agent chemotherapy of ≥ 4 cycles or ≥ 12 weeks that included a taxane before or after surgery. This study is evaluating the effect of using a targeted drug ribociclib (Kisqali) along with a standard anti-estrogen drug in patients who have already had surgery and chemotherapy and are at high risk for recurrence. Kisqali is a CDK4/6 inhibitor. It is approved for use along with an aromatase inhibitor to treat postmenopausal women with HR+, HER2-negative advanced breast cancer. You will receive one of these hormone therapies: tamoxifen (Nolvadex®), letrozole (Femara®), anastrozole (Arimidex®), or exemestane (Aromasin®). If you are premenopausal, you will also receive a drug to shut down your ovaries.
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 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

GS-5829 plus Exemestane or Fulvestrant for Advanced ER+ HER2- Breast Cancer

A Phase 1b Study Followed by an Open Label, Parallel, Randomized Phase 2 Study Evaluating the Safety, Tolerability and Efficacy of GS-5829 in Combination With Exemestane or Fulvestrant Comparing With Exemestane or Fulvestrant Alone in Subjects With Advanced Estrogen Receptor Positive HER2- Breast Cancer (NCT02983604)

Summary

To take part in this study, you must be postmenopausal and have ER-positive, HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. Also, your cancer must have started growing while you were on an anti-estrogen drug. There are two phases in this study. Phase 1 will identify the best dose and the safety of a new targeted drug when it is used along with an anti-estrogen drug. Phase 2 will look at whether women who take the new drug along with an anti-estrogen drug are less likely to have their cancer progress than women who take only an anti-estrogen drug. The targeted drug being used in this study is called GS-5829. The anti-estrogen drugs are exemestane (Aromasin®) and fulvestrant (Faslodex®). Both are commonly used to treat advanced ER+ breast cancer in postmenopausal women.
This is a Phase I-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

GDC-0077 & HormoneTherapy 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

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

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

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

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.