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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+).

Targeted Therapies Plus Chemo Before Surgery For ER+, HER2+ Breast Cancer

Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Taxotere, Trastuzumab and Pertuzumab) in Patients With HER2-positive and ER-Positive Breast Cancer (NeoHTTP Study) (NCT02345772)

Summary

Giving therapy before surgery -- called neoadjuvant treatment -- allows doctors to study how well a tumor responds to a cancer regimen. If the therapy is successful, there are no cancer cells remaining at the time of surgery--and the patient is said to have had a "pathologic complete response." Some studies have suggested that women who have a pathologic complete response after neoadjuvant treatment have a better prognosis. Fulvestrant (Faslodex®) is a hormone therapy used to treat ER+ metastatic breast cancer in postmenopausal women who have tried other hormone therapies. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat breast cancer. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2 targeted therapies. This study will look at the effectiveness of using Faslodex, Taxotere, Herceptin and Perjeta to obtain a pathologic complete response in women with ER+, HER2+ breast cancer.

What's Involved    Contact information

Chemotherapy, Herceptin, Perjeta & an AI Before Surgery for ER+, HER2+ Stage I-III Tumors

A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients With Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated With Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation (NCT02003209)

Summary

Researchers are trying to determine the best treatment for ER+, HER2+ tumors. Docetaxel (Taxotere®) and carboplatin (Paraplatin®) are two types of chemotherapy drugs used to treat breast cancer. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2+ tumors. This four drug combination is called TCHP. Aromatase inhibitors (AIs) are used to treat ER+ tumors in postmenopausal women. Premenopausal women can use an AI if they also take Goserelin (Zoladex®), a drug that stops ovarian function. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study the effect that a treatment has on cancer cells. This study is comparing the effect of giving TCHP with an AI to giving TCHP alone before surgery to women with stage I-III breast cancer. Following treatment, all of the women will have a lumpectomy or mastectomy followed by whole breast radiation and one year of Herceptin.
This is a Phase III trial

What's Involved    Contact information

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

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

What's Involved    Contact information

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

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

Summary

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

  • Participation TimeVisits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation Time2 visits per month
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Femara® Before Surgery in Postmenopausal Women With ER+ DCIS

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

Summary

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

What's Involved    Contact information

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.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Endoxifen for Locally Recurrent or Metastatic Breast Cancer

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

Summary

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

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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

What's Involved    Contact information

Letrozole Before Surgery in Postmenopausal Women

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

Summary

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

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Study of Tamoxifen Effectiveness on Treating Advanced Disease

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

Summary

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

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BKM120 After an AI & an mTOR Inhibitor for Advanced Disease

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

Summary

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

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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

What's Involved    Contact information

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

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

Summary

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

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Arimidex® and Fulvestrant Before Surgery

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

Summary

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

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

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

Summary

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

What's Involved    Contact information

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

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Saracatinib and Anastrozole for ER-Positive Disease

A Phase I Pharmacokinetic and Randomized Phase II Trial of Neoadjuvant Treatment With Anastrozole Plus AZDO530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer (NCT01216176)

Summary

Researchers are developing new treatments that can target and block enzyme proteins, like Src and Abl, that tell cancer cells to grow. Saracatinib (AZD0530) is a new drug that scientists believe will inhibit both Src and Abl. The goal of this trial is to determine the safety and effectiveness of saracatinib when it is given along with the aromatase inhibitor anastrozole (Arimidex®). In the first part of this study (Phase I), researchers will enroll women with metastatic or locally advanced disease that cannot be removed by surgery. In the second part of this study (Phase II), researchers will enroll women with Stage II or III disease who are planning to have standard surgery.
This is a Phase I-II trial

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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.

  • Participation TimeVisits every 2 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeMonthly visits
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Abemaciclib + Arimidex Before Surgery in Postmenopausal Women with HR+, HER2- Tumors

neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib... (NCT02441946)

Summary

Abemaciclib (LY2835219) is a new type of targeted therapy called a CDK 4/6 inhibitor. Anastrozole (Arimidex®) is an aromatase inhibitor routinely used to treat postmenopausal women with hormone sensitive breast cancer. This study is comparing the effectiveness of abemaciclib and Arimidex to abemaciclib alone and Arimidex alone when the treatments are given before surgery to postmenopausal women with HR+, HER2- breast cancer.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

ARN-810 in Postmenopausal Women With Advanced Breast Cancer

An Open-Label, Phase I Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer (NCT01823835)

Summary

Over time, hormone-sensitive tumors can stop responding to hormone therapies. ARN-810 is a new type of anti-estrogen drug called a selective estrogen receptor degrader. It is designed to block and destroy the hormone receptors that drive tumor growth. Laboratory studies suggest it may be effective in women who have stopped responding to other hormonal therapies. This study is looking at the safety and the most effective dose of ARN-810 for treating postmenopausal women with locally advanced or metastatic hormone-sensitive, HER2-negative breast cancer who have already tried previous hormone therapies.
This is a Phase I trial

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HER2 Therapies with Hormone Therapy or Chemotherapy for Advanced Breast Cancer

1303GCC: Phase II Study of Trastuzumab and Pertuzumab Alone and in Combination With Hormonal Therapy or Chemotherapy With Eribulin in Women Aged 60 and Over With HER2/Neu Overexpressed Locally Advanced and/or Metastatic Breast Carcinoma (NCT02000596)

Summary

Researchers are studying new treatment combinations for advanced HER2+ breast cancer. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2 targeted therapies used to treat HER2+ breast cancer. Anastrozole (Arimidex®) and fulvestrant (Faslodex®) are two of the hormone therapies used to treat advanced breast cancer. Eribulin (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer. Patients who enroll in this study will initially receive Herceptin and Perjeta. If their tumors progress on this treatment, they will receive either Arimidex and Faslodex or Halaven in addition to Herceptin and Perjeta. This study is open to postmenopausal women with locally advanced or metastatic breast cancer.
This is a Phase II trial

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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.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

BYL719 & Femara for Hormone-Sensitive Metastatic Breast Cancer

A Phase Ib Trial of BYL719 (an α-Specific PI3K Inhibitor) in Combination With Endocrine Therapy in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer (NCT01791478)

Summary

Researchers are studying new drugs and new drug combinations that may be effective in patients with metastatic breast cancer. BYL719 is a new targeted therapy that works by blocking a protein called PI3K that plays a role in tumor growth. Letrozole (Femara®) is a hormone therapy that is used to treat early-stage and metastatic breast cancer. BYL719 combined with Femara may be more effective than using Femara alone. This trial is studying the side effects and best dose of BYL719 when it is given with Femara to patients with hormone-sensitive metastatic breast cancer.
This is a Phase I trial

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LEE011 in Premenopausal Women with Hormone-Sensitive HER2-Negative Advanced Breast Cancer

A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer (MONALEESA7) (NCT02278120)

Summary

Researchers are studying new types of targeted therapies. LEE011 is a new targeted therapy that inhibits two enzymes--CDK4 and CDK6--that help tumors grow. Anastrozole (Arimidex®) and letrozole (Femara®) are two of the aromatase inhibitors (AIs) used to treat hormone-sensitive breast cancer in postmenopausal women. Premenopausal women can only use an AI if they also take a drug that will stop their ovaries from making estrogen. Goserelin (Zoladex®) is one of these drugs. Tamoxifen (Nolvadex®) is a hormone therapy used to treat hormone-sensitive breast cancer in pre- and post-menopausal women. In premenopausal women it can also be given with Zoladex. This study is comparing the effectiveness of giving a hormone therapy and Zoladex alone or with LEE011 to treat premenopausal women with hormone-sensitive HER2-negaitve advanced breast cancer.
This is a Phase III trial

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BYL719 with Aromasin and/or Afinitor in Advanced Breast Cancer

A Phase Ib Dose-finding Study of BYL719 Plus Everolimus and BYL719 Plus Everolimus Plus Exemestane in Patients With Advanced Solid Tumors, With Dose-expansion Cohorts in Renal Cell Cancer (RCC), Pancreatic Neuroendocrine Tumors (pNETs), and Advanced Breast Cancer (BC) Patients. (NCT02077933)

Summary

Researchers are looking at the effectiveness of combining new targeted therapies with other types of breast cancer treatments. BYL719 is a new type of drug called a PI3K inhibitor. It is designed to slow or stop cancer cell growth by blocking the activity of the PI3K protein. Exemestane (Aromasin®) is an aromatase inhibitor that is routinely used to treat hormone-sensitive breast cancer. Everolimus (Afinitor®) is an mTOR inhibitor that is given along with Aromasin to treat advanced hormone-sensitive breast cancer. This study is designed to determine the highest dose and the safety of BYL719 when it is given with Afinitor or Afinitor and Aromasin to treat patients with advanced breast cancer who have no other standard treatments available. The study is also enrolling patients with advanced liver and pancreatic cancer.
This is a Phase I trial

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RAD1901 for Advanced ER+ and HER2- Breast Cancer

A Phase I, Multicenter, Open-Label, Two-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer (NCT02338349)

Summary

Over time, hormone-sensitive tumors can stop responding to hormone therapy. Researchers are looking for ways to overcome this problem. RAD1901 is an investigational targeted therapy that is designed to prevent tumor growth by destroying the estrogen receptor (ER). This study is looking at the safety, efficacy and best dose of RAD1901 in post-menopausal women with advanced ER+, HER2- breast cancer. To be eligible, a patient must have received no more than two prior chemotherapy regimens and at least six months of hormone therapy.
This is a Phase I trial

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A PI3K Inhibitor & Femara® Before Surgery in HR+, HER2- Tumors

A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer (NCT01923168)

Summary

Over time, cancer cells may stop responding to hormone therapy. Letrozole (Femara®) is a hormone therapy. BKM120 and BYL719 are PI3K inhibitors. They work by blocking the PI3K pathway in cancer cells. Laboratory studies suggest blocking this pathway may get tumors to respond longer to hormone therapy. This study is looking at the effect that BKM120 and Femara; BYL719 and Femara; and Femara alone have on cancer cells in patients with early-stage ER+, HER2- tumors. Women interested in this trial will have their tumor tested for the PIK3CA mutation. Only those whose tumors test positive will be able to enroll in the study.
This is a Phase II trial

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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

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MLN0128 With Hormone Therapy in ER+, HER2- Metastatic Breast Cancer

A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant (NCT02049957)

Summary

Targeted therapies called mTOR inhibitors are a new type of cancer treatment. Everolimus (Afinitor®) is an mTOR inhibitor. Exemestane (Aromasin®) is an aromatase inhibitor used to treat postmenopausal women. Fulvestrant (Faslodex®) is a hormone therapy used to treat women with hormone-sensitive tumors that have stopped responding to anti-estrogens. MLN0128 is a new mTOR kinase inhibitor that may work better than Afinitor. This study is investigating the safety and effectiveness of using MLN0128 along with Aromasin compared with using MLN0128 along with Faslodex to treat women with ER+, HER2- advanced breast cancer who have progressed on treatment with Afinitor in combination with Aromasin or Faslodex.
This is a Phase I-II trial

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites: 17 sites total Contact information
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Xofigo, Xgeva & Hormone Therapy to Treat ER+ Bone Metastases

Phase II Trial of Ra-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. Ra-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

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LEE011, Afinitor & Aromasin in ER+ HER2- Advanced Breast Cancer

A Phase Ib/II Trial of LEE011 in Combination With Everolimus (RAD001) and Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive, Her2- Locally Advanced or Metastatic Breast Cancer (NCT01857193)

Summary

LEE011 is a new oral drug that targets two enzymes--CDK4 and CDK6--that play a role in cell growth. Laboratory studies suggest LEE011 can slow or stop the growth of cancer cells. Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. Exemestane (Aromasin®) is used to treat hormone-sensitive tumors. Afinitor is used along with Aromasin to treat ER+, HER2- advanced breast cancer. This study is comparing the safety and tolerability of using the combination of LEE011, Afinitor, and Aromasin, or the combination of LEE011 and Aromasin, to the safety and tolerability of Afinitor and Aromasin in women ER+, HER2- advanced breast cancer.
This is a Phase I-II trial

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Afinitor and an Anti-Estrogen Therapy for ER/PR+, HER2- Advanced Breast Cancer

Phase II Open Label Study of Everolimus in Combination With Anti-estrogen Therapy in Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer (NCT02291913)

Summary

Everolimus (Afinitor®) is a new type of targeted therapy called an mTOR inhibitor. It is used to treat advanced hormone-sensitive, HER2- breast cancer along with the anti-estrogen therapy exemestane (Aromasin®) in postmenopausal women who have already received certain other treatments. Researchers believe this treatment works in part because it gets the cancer cells to start responding again to the anti-estrogen therapy. It is not known whether Afinitor will get tumors to start responding again to other anti-estrogen therapies. In this study patients will receive Afinitor along with the anti-estrogen therapy they were taking when their cancer progressed. (The anti-estrogen therapy can be tamoxifen, fulvestrant/Faslodex®, anastrozole/Arimidex®, letrozole/Femara®, exemestane/Aromasin®, toremifene/Fareston®, or an LHRH agonist given with anti-estrogen therapy).
This is a Phase II trial

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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

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Fulvestrant & Ganetespib for Hormone-Sensitive Advanced Disease

Randomized Phase II Study of Fulvestrant With or Without Ganetespib in Patients With Hormone Receptor-Positive, Metastatic Breast Cancer (NCT01560416)

Summary

Over time, tumors often become resistant to the drugs being used to treat them. The investigational drug ganetespib (STA-9090) is an HSP90 inhibitor. It works by blocking HSP90 (heat shock protein 90), a molecular chaperone that plays a role in cell signaling. This reduces the ability of cancer cells to become resistant to treatment. Fulvestrant (Faslodex®) is used to treat metastatic, estrogen-sensitive tumors. It works by keeping estrogen from getting into the cancer cells; it also decreases the number of estrogen receptors on the cancer cells. In the laboratory, adding ganetespib to fulvestrant appears to improve its effectiveness. It is not yet known whether this is true in humans. This research study is evaluating the effect of adding ganetespib to fulvestrant for the treatment of hormone-sensitive metastatic breast cancer.
This is a Phase II trial

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Aromasin® and Entinostat For ER+, HER2-, Advanced Breast Cancer

A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Postmenopausal Patients With Hormone Receptor-Positive Advanced Breast Cancer (NCT02115282)

Summary

Exemestane (Aromasin®) is a type of hormone therapy that is routinely used to treat postmenopausal women with hormone-sensitive breast cancer. Entinostat is a new type of drug called a histone deacetylase (HDAC) inhibitor. It works by blocking HDAC enzymes, which are needed for cell growth. In this study, researchers are investigating whether using Aromasin and entinostat together is more effective than using Aromasin alone to treat men and postmenopausal women with hormone-sensitive, HER2-negative advanced breast cancer.
This is a Phase III trial

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Pazopanib to Reverse Resistance to Hormone Therapy

Reversing Hormone Resistance in Advanced Breast Cancer With Pazopanib (NCT01466972)

Summary

Anti-estrogen therapies are used to treat breast tumors that are hormone sensitive. Over time, some tumors will stop responding to these treatments. Researchers are looking for ways to get a breast tumor that has stopped responding to hormone therapy to start responding again to this treatment. The tyrosine kinase inhibitor pazopanib (Votrient®) is currently used to treat kidney cancer. It works by interfering with cell communication and growth. Studies suggest it may also be able to get hormone-sensitive tumors to begin responding again to anti-estrogen therapies. The goal of this trial is to investigate the effectiveness of giving pazopanib to individuals whose cancer has progressed while on letrozole (Femara®) or anastrozole (Arimidex®).
This is a Phase II trial

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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

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

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

Summary

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

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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

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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.

  • Participation TimeVisits every 3 weeks, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
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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

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Measuring Breast Density in Premenopausal Breast Cancer Patients on Tamoxifen

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

Summary

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

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