Home   /  Find a Trial  /  See All TrialsClick to print page Print
 

See All Trials

QuickViews

by Tumor Type:

Inflammatory Breast Cancer
Biomarker status:
 Hormone-positive (ER+ and/or PR+)
 HER2-positive (HER2+)
 Triple negative (ER-/PR-/HER2-)
Inflammatory Breast Cancer
Biomarker status:
 Hormone-positive (ER+ and/or PR+)
 HER2-positive (HER2+)
 Triple negative (ER-/PR-/HER2-)

Sites with evidence of disease:

Triple Negative Breast Cancer
Sites with evidence of disease:


by Trial Type:

 

see All Trials

Sort by zipcode:  

Share

Twitter
Facebook
 
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+).

TAK-700 in Postmenopausal Women with ER+ Advanced Disease

CO11109: A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer (NCT01808040)

Summary

Researchers are studying new types of drugs that may be effective against hormone-sensitive metastatic breast cancer. Orteronel (TAK-700) is a drug that blocks hormone production. It is currently in phase III trials for the treatment of metastatic prostate cancer. Laboratory studies suggest it may be effective in postmenopausal women with hormone-sensitive metastatic breast cancer. This study is designed to test the safety and effectiveness of orteronel (TAK-700) and to determine the best dose for use in future trials. To be eligible, participants must be postmenopausal and can not have tried more than one previous anti-estrogen drug for metastatic breast cancer.
This is a Phase I trial

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

Estradiol and Aromasin® for Hormone Therapy-Resistant Disease

A Pilot Study Of Estradiol Followed By Exemestane For Post-Menopausal Hormone Receptor Positive Metastatic Breast Cancer After Prior Failed Endocrine Therapy: Reversing Endocrine Resistance (NCT01385280)

Summary

Over time, hormone-sensitive tumors can stop responding to anti-estrogen treatments such as aromatase inhibitors (AI). Estradiol is a type of estrogen produced in the body. Laboratory studies have found that estradiol stops acting like an estrogen after resistance to an AI has developed. Instead it kills cancer cells that have become resistant to the AI. It also gets the tumor to start responding again to an AI. This pilot study is investigating the effectiveness of estradiol followed by the AI exemestane (Aromasin®) in postmenopausal women with hormone-sensitive metastatic breast cancer that has stopped responding to an AI.

Letrozole/Lapatinib/Everolimus For Endocrine Resistant Disease

GCC 0901- A Phase II Study of Letrozole in Combination With Lapatinib Followed by an Addition of Everolimus in Postmenopausal Women With Advanced Endocrine Resistant Breast Cancer (NCT01499160)

Summary

Over time, tumors that are hormone-sensitive can stop responding to endocrine (anti-estrogen) therapies. Letrozole (Femara®) is a drug used to treat hormone-sensitive tumors. Lapatinib (Tykerb®) is used to treat HER2-positive metastatic breast cancer. (The study will include patients with both HER2-negative and HER2-positive tumors. The use of lapatinib in HER2-negative patients is considered experimental.) Everolimus (Afinitor®) is used to treat kidney cancer. Studies suggest it may also be an effective breast cancer treatment. Laboratory studies have shown that combining Tykerb and Afinitor with Femara can get tumors to start responding again to Femara. If is not known if the same effect will be seen in breast cancer patients. The purpose of this study is to find out whether Femara, Tykerb and Afiinitor will get tumors to start responding again to anti-estrogen therapy.
This is a Phase II trial

Comparing First-Line Faslodex & Arimidex for Advanced Tumors

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With... (NCT01602380)

Summary

Researchers are trying to determine which anti-estrogen drug is most effective in postmenopausal women with locally advanced or metastatic breast cancer who have not had prior hormonal therapy. (This is referred to as "first-line" treatment.) Fulvestrant (Faslodex®) is approved for the treatment of postmenopausal women with metastatic hormone-sensitive breast cancer who have already been treated with other anti-estrogens. Anastrozole (Arimidex®) is used to treat early and advanced hormone-sensitive breast cancer in postmenopausal women. The purpose of the study is to compare the effectiveness of Faslodex and Arimedex as a first-line treatment for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.
This is a Phase III trial

  • Participation Time3 visits in first month, then monthly visits thereafter
  • Participating research sites Nearest research site: Contact sponsor; 26 sites total

Letrozole Before Surgery in Postmenopausal Women

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

Summary

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

The Effect of Oral Proellex on Breast Cancer Cells

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

Summary

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

AZD2014 and Fulvestrant in ER+ Metastatic Breast Cancer

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites Nearest research site: Contact sponsor; 4 sites total

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

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

Vorinostat + An Aromatase Inhibitor for Stage IV Breast Cancer

A Pilot Study of Vorinostat to Restore Sensitivity to Aromatase Inhibitor Therapy Part B (NCT01720602)

Summary

Over time, many hormone-sensitive tumors stop responding to hormone therapy. Vorinostat (Zolinza®) is a type of cancer treatment called a histone deacetylase (HDAC) inhibitor. It is currently used to treat a type of lymphoma. Studies suggest it can improve the way a tumor responds to hormone therapy. This study is looking at the effect of combining vorinostat with an aromatase inhibitor to treat patients with hormone-sensitive metastatic breast cancer.

BKM120 & Fulvestrant in Advanced ER or PR+, HER2- Tumors

A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed ... (NCT01610284)

Summary

Researchers are trying to develop new drugs that will be effective in advanced hormone-sensitive (ER and/or PR+) tumors that have stopped responding to an aromatase inhibitor. BKM120 is an investigational biological therapy that works by blocking PI3K, a group of proteins that help cancer cells to grow. 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 investigating the safety and effectiveness of adding daily BKM120 to Faslodex in patients with hormone sensitive, HER2-negative advanced breast cancer that has stopped responding to an aromatase inhibitor.
This is a Phase III trial

Endoxifen For Hormone Receptor-Positive Metastatic Disease

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

Summary

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

Chemotherapy or Hormonal Therapy Before Surgery

Randomized, Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) or Exemestane in Patients With Hormone Receptor-Positive Breast Cancers With Recurrence Scores Less Than 25 (≤ 24) (NCT00941330)

Summary

Chemotherapy or hormonal therapy is sometimes given before surgery to shrink the size of a large breast tumor and reduce the amount of tissue that needs to be removed. This is called "neoadjuvant" treatment. Giving these therapies before surgery also allows researchers to study how the tumor responds. Exemestane (Aromasin®) is an aromatase inhibitor that it is used to treat hormone-sensitive breast cancer. It works by blocking the production of estrogen. Docetaxel (Taxotere®) and cyclophosphamide (Cytoxan®) are chemotherapy drugs that are commonly used to treat breast cancer. Oncotype DX is a test performed on tumor tissue to assess a patient's risk of recurrence. The purpose of this study is to compare the effectiveness of Aromasin® with the combination of docetaxel and Cytoxan® when the therapies are given before surgery to shrink hormone-sensitive tumors. To be eligible for this trial, patients must have an Oncotype DX score of 24 or less.
This is a Phase II trial

Arimidex® and Fulvestrant Before Surgery

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

Summary

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

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

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

Summary

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

A Study of How Femara® Affects Breast Cancer Cells

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

Summary

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

Arimidex and Faslodex in Postmenopausal Women with ER+ Tumors

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

Summary

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

Saracatinib and Anastrozole for ER-Positive Disease

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

Summary

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

Everolimus Plus Femara in ER+ Advanced Breast Cancer

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

Summary

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

ARN-810 in Postmenopausal Women With Advanced Breast Cancer

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

Summary

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

BYL719 & Femara for Hormone-Sensitive Metastatic Breast Cancer

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

Summary

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

MK-2206 & Arimidex Before Surgery for Stage II-III Tumors

A Phase II Trial of Neoadjuvant MK-2206 in Combination With Either Anastrozole if Postmenopausal or Anastrozole and Goserelin if Premenopausal in Women With Clinical Stage 2 or 3 PIK3CA Mutant Estrogen Receptor Positive, HER2 Negative... (NCT01776008)

Summary

Researchers are looking at the effectiveness of combining a targeted therapy with an aromatase inhibitor (AI). MK-2206 is a new targeted therapy that works by blocking Akt, a protein that helps tumors grow. Anastrozole (Arimidex®) is one of the AIs used to treat breast cancer. This trial is studying the effectiveness of and side effects associated with giving MK-2206 along with Arimidex to women with stage II or stage III breast cancer. Women who are premenopausal will also receive goserelin acetate (Zoladex®), a drug that temporarily shuts down the ovaries, allowing premenopausal woman to take an AI. If you are interested in the trial, your tumor will be tested to see if it has a PIK3CA mutation. To be eligible, participants must test positive for the PIK3CA mutation.
This is a Phase II trial

Determining the Best Dose of LEE011 By Giving it Before Surgery

A Randomized Pre-surgical Pharmacodynamics Study to Assess the Biological Activity of LEE011 Plus Letrozole Versus Single Agent Letrozole in Primary Breast Cancer (NCT01919229)

Summary

LEE011 is a new oral, targeted therapy that works by inhibiting enzymes (CDK4 and CDK6) that are necessary for cell growth. Previous studies have shown that combining LEE011 with hormone therapy may prevent breast cancer cells from developing resistance to hormone therapy. Letrozole (Femara®) is a commonly used hormone therapy. This study is looking at the biological effect that two different doses of LEE011 given before surgery (neoadjuvant therapy) have on breast cancer cells when used in combination with Femara compared with Femara alone. To be eligible, a woman must be postmenopausal and not yet had any breast cancer treatment.
This is a Phase II trial

Faslodex +/- Afinitor for AI-Resistant Advanced Breast Cancer

Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) Plus Everolimus in Post-Menopausal Patients With Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy (NCT01797120)

Summary

Some patients with ER+ tumors don't respond to hormone therapy. Others have ER+ tumors that initially respond but, over time, become resistant. Fulvestrant (Faslodex®) is a hormone therapy that is commonly used when an ER+ tumor stops responding to an aromatase inhibitor (AI). Everolimus (Afinitor®) is an mTOR inhibitor. It is currently used along with the AI exemestane (Aromasin) to treat advanced ER+, HER2- breast cancer. Using Afinitor along with Faslodex may be more effective than using Faslodex alone. This study is comparing the safety and effectiveness of Afinitor and Faslodex to Faslodex alone in women with advanced hormone-sensitive tumors who have already been on an AI.
This is a Phase II trial

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

PD 0332991 & Arimidex Before Surgery for ER+, HER2- Tumors

A Phase II Trial of Neoadjuvant PD 0332991, a Cyclin-Dependent Kinase (Cdk) 4/6 Inhibitor, in Combination With Anastrozole in Women With Clinical Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer (NCT01723774)

Summary

PD 0332991 (palbociclib isethionate) is a new oral drug that works by blocking a family of enzymes that control cell division. Anastrozole (Arimidex®) is used routinely to treat hormone-sensitive tumors. Giving anti-cancer medications before surgery (neoadjuvant treatment) allows researchers to see how the tumor responds to the drugs being studied. The goal of this trial is to investigate the safety and effectiveness of giving PD 0332991 along with Arimidex before surgery to women with stage II or stage III ER+, HER2- breast cancer. To be eligible, participants must have tested negative for the PIK3CA mutations.
This is a Phase II trial

Palbociclib and an Aromatase Inhibitor for Stage II-III ER+, HER2- Breast Cancer

A Phase 2 Pilot Feasibility Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive Invasive Breast Cancer (NCT02040857)

Summary

Palbociclib (PD-0332991) is a new type of targeted therapy called a CDK inhibitor. It blocks two enzymes, called CDK 4 and 6, that are part of a pathway that regulates cell growth. Laboratory studies suggest that palbociclib may be effective against hormone sensitive breast cancer. Aromatase inhibitors (AIs) are routinely used to treat post-menopausal women with hormone-sensitive breast cancer. The AIs currently used are letrozole (Femara®), Anastrazole (Arimidex®), and Exemestane (Aromasin®.) This study is looking at the effectiveness of combining palbociclib with an AI in postmenopausal women with stage II or stage III breast cancer. To be eligible, participants must have been on an AI for at least 3 months without experiencing side effects that would prohibit them from taking an AI for at least two years. Patients may enroll at any point within two years of starting on an AI, as long as they plan to be on an AI for at least two more years.
This is a Phase II trial

Arimidex® & Targeted Therapy for Advanced Breast Cancer

Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance (NCT01197170)

Summary

Researchers are studying new drug combinations that can be used to treat advanced breast cancer. The goal of this study is to identify the highest tolerated dose of the aromatase inhibitor anastrozole (Arimidex®) when it is given alone or in combination with everolimus (Afinitor®), sorafenib (Nexavar®), erlotinib (Tarceva®), fulvestrant (Faslodex®), or bevacizumab (Avastin®), all of which can be used to treat advanced breast cancer. During the course of the study, if a patient develops resistance to the two drug combination, a third drug will be added to the treatment regimen. To be eligible, participants must have advanced or metastatic cancer that has not responded to standard therapy.
This is a Phase I trial

Fulvestrant & Ganetespib for Hormone-Sensitive Advanced Disease

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

Summary

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

Dovitinib Plus an Aromatase Inhibitor for Metastatic Disease

A Phase I/II Trial of TKI258 (Dovitinib) in Combination With an Aromatase Inhibitor in Patients With Metastatic Breast Cancer (NCT01484041)

Summary

Over time, hormone-sensitive tumors can stop responding to an aromatase inhibitor (AI). Dovitinib (TKI258) is a new targeted therapy that works by blocking the tyrosine kinase receptor on cancer cells. This receptor is like an on/off switch for many cell functions, and blocking it can keep cancer cells from getting the messages they need to grow and divide. This trial is investigating the effectiveness of and side effects associated with using dovitinib along with one of the AIs—anastrozole (Arimidex®), letrozole (Femara®) or exemestane (Aromasin®). To be eligible, a woman must have already been on an AI to treat her metastatic breast cancer.
This is a Phase I-II trial

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

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

Summary

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

Aromasin® and Cytoxan® for Hormone Sensitive Metastatic Breast Cancer

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

Summary

This phase II trial studies how well exemestane and cyclophosphamide work in treating patients with estrogen receptor (ER) -positive, progesterone receptor (PR) -positive, and human epidermal growth factor receptor (HER)2-negative stage IV breast cancer.
This is a Phase II trial

Enzalutamide For Treating Metastatic Breast Cancer

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

Summary

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

Finding Biomarkers to Predict Which Tumors Will Respond to Tamoxifen

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

Summary

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

Circulating Tumor Cells to Predict Response to Hormone Therapy

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

Summary

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

Measuring Breast Density in Premenopausal Breast Cancer Patients on Tamoxifen

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

Summary

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