Home   /  Find a Trial  /  See All TrialsHELP  /   AYUDA  /   求助 : help-desk@bctrials.org  /   (415) 476-5777Click to print page Print
 
Match To Trials
Our Matching Service can help you find trials that are right for you.
 
Subscribe to our Newsletter

Stay Informed

Enter your email in the box below to receive our monthly e-newsletter.

We will never sell or rent your information. Your details are protected by our privacy policy.
 

browse by Tumor Type

Sort by zipcode:  

Share

Twitter
Facebook
Stage I-III Breast Cancer -- Triple Negative

Last updated: December 6, 2016


Chemotherapy

AC Chemo Followed by Taxol with or without Paraplatin for Triple-Negative Breast Cancer

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast CancerDoxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer (NCT02488967)

Summary

Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC--and paclitaxel (Taxol®) are chemotherapy drugs routinely used to treat breast cancer. Carboplatin (Paraplatin®) is a platinum-based chemotherapy drug that studies suggest is effective for triple-negative breast cancer. This study is comparing the effectiveness of AC followed by Taxol followed by Paraplatin to AC followed by Taxol in patients with triple-negative breast cancer. To be eligible, participants must have had breast cancer surgery with clean margins (cancer-free area around where tumor was removed). Patients who did not have clean margins will need to have radiation therapy to the chest wall before entering the trial.
This is a Phase III trial

Carboplatin with Other Chemotherapy Drugs Before Surgery for Triple Negative Breast Cancer

Randomized, Open Label, Phase II Trial of Neoadjuvant Carboplatin Plus Docetaxel or Carboplatin Plus Paclitaxel Followed by AC in Stage I-III Triple-negative Breast Cancer (NCT02413320)

Summary

Carboplatin (Paraplatin®) is a platinum-based chemotherapy drug used to treat advanced breast cancer that has not responded to previous chemotherapy treatments. Paclitaxel (Taxol®) and docetaxel (Taxotere®) are chemotherapy drug commonly used to treat advanced breast cancer. Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC--is routinely used to treat breast cancer. Giving chemotherapy before surgery--called neoadjuvant treatment--allows researchers to study how the tumor responds to the treatment regimen. Previous studies have found that Paraplatin and Taxotere are well tolerated in the neoadjuvant setting. This study is comparing the safety and effectiveness of Paraplatin and Taxol followed by AC with Paraplatin and Taxotere when given before surgery to women with early stage triple negative breast cancer. To be eligible, participants must be enrolled in the Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry (PROGECT).
This is a Phase II trial

Everolimus & Cisplatin after Neoadjuvant Chemo & Surgery for Triple-Negative Tumors

NEOADJUVANT PHASE II STUDY OF EVEROLIMUS PLUS CISPLATIN IN TRIPLE NEGATIVE BREAST CANCER PATIENTS WITH RESIDUAL DISEASE AFTER STANDARD CHEMOTHERAPY (NCT01931163)

Summary

Researchers are looking at the effectiveness of combining chemotherapy drugs with targeted therapies. Cisplatin (Platinol®) is a chemotherapy drug routinely used to treat breast cancer. Everolimus (Afinitor®) is a targeted therapy used to treat advanced hormone receptor-positive, HER2-negative breast cancer. This study is looking at the safety and effectiveness of using Platinol and Afinitor to treat patients with triple negative tumors who had chemotherapy before surgery (neoadjuvant treatment) that did not fully shrink the tumor.
This is a Phase II trial

Vectibix, Paraplatin & Taxol Before Surgery For Early Stage Triple Negative Disease

Women's Triple-Negative First-Line Study: A Phase II Trial of Panitumumab, Carboplatin and Paclitaxel (PaCT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NCT02593175)

Summary

To take part in this study, you must have been diagnosed with triple-negative, early-stage breast cancer but not yet had surgery. In addition, you must have a type of tumor that is not likely to get smaller if you receive the standard type of chemotherapy given before surgery. Vectibix, Paraplatin, and Taxol are three different types of cancer drugs. Researchers think that giving all three drugs at the same time before surgery will shrink triple negative tumors. Panitumumab (Vectibix®) is a targeted treatment used to treat certain types of colorectal cancer. Its use in breast cancer is considered experimental. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs that are used to treat breast cancer.
This is a Phase II trial

Radiation & Chemotherapy Together or Sequentially for Early-Stage, ER- Breast Cancer

"Randomized Trial of Partial Breast Irradiation (PBI) and Sequential vs. Concurrent Chemotherapy in Women With ER Negative Early Stage Breast Cancer (PBI 3.0)" (NCT01928589)

Summary

Following surgery, patients with ER-negative breast cancer typically receive radiation followed by chemotherapy. Previous studies suggest that giving radiation therapy and chemotherapy at the same time is also a safe and effective way to treat early-stage ER-negative breast cancer. Partial-breast irradiation (PBI) is a type of radiation therapy given only to the area of the breast where the cancer was removed. This study will compare the safety and effectiveness of giving PBI and chemotherapy at the same time with giving PBI followed by chemotherapy in patients with early-stage ER-negative breast cancer.
This is a Phase I-II trial

Chemotherapy and a Targeted Therapy Before Surgery for Stage III Breast Cancer

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting (NCT02436993)

Summary

Stage II and III tumors are typically treated with chemotherapy before surgery. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs routinely used to treat breast cancer. Bevacizumab (Avastin®) is a targeted therapy that keeps tumors from growing the blood vessels they need to survive. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2-positive breast cancer. In this study patients with HER2-negative tumors will receive chemotherapy and Avastin and patients with HER2-positive tumors will receive chemotherapy along with Herceptin and Perjeta. Researchers will evaluate the safety and efficacy of the two treatment protocols. They will also investigate whether magnetic resonance imaging (MRI) is a good tool for monitoring and predicting how the tumor will respond to the treatment.
This is a Phase II trial

MEDI4736 and Chemotherapy Before Surgery for Stage I-III Triple Negative Breast Cancer

Single Arm Neoadjuvant Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) Concomitant With Weekly Nab-paclitaxel and Dose-dense Doxorubicin/Cyclophosphamide (ddAC) Chemotherapy for Clinical Stage I-III Triple Negative Breast Cancer (NCT02489448)

Summary

MEDI4736 is a new immunotherapy drug. By blocking a protein called PD-1 (programmed cell death 1), it allows the immune system to go after cancer cells. Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC chemotherapy--and nab-paclitaxel (Abraxane®) are routinely used to treat breast cancer. Giving MEDI4736 with this chemotherapy regimen before surgery (called neoadjuvant therapy) may make the chemotherapy more effective. This study will investigate the best dose and effectiveness of MEDI4736 for use with this chemotherapy regimen when it is given before surgery to individuals with stage I-III triple negative breast cancer.
This is a Phase I-II trial

Taxotere and Paraplatin Before Surgery in ER-, HER2- Stage II-III Breast Cancer

A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery (NCT02124902)

Summary

Researchers are trying to determine the best treatments for triple negative (ER-, PR-, HER2-) breast cancer. Giving chemotherapy before surgery, called neoadjuvant therapy, allows researchers to study the effect that the treatment has on cancer cells. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat advanced breast cancer. Carboplatin (Paraplatin®) is a chemotherapy drug used to treat advanced breast cancer that has not responded to previous chemotherapy treatments. This study is looking at the effect that Taxotere and Paraplatin have on cancer cells when they are given before surgery to treat patients with stage II or stage III triple-negative breast cancer.
This is a Phase II trial

Doxil, Avastin and Torisel Before Surgery for Triple-Negative Breast Cancer

Women's Triple-Negative First-Line Study: A Phase II Trial of Liposomal Doxorubicin, Bevacizumab and Temsirolimus (DAT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NCT02456857)

Summary

In this study, participants will receive the experimental drug regimen DAT, which consists of liposomal doxorubicin (Doxil®), bevacizumab (Avastin®), and temsirolimus (Torisel®). Doxil is a chemotherapy drug used to treat breast cancer. Avastin works by keeping the cancer from making the blood vessels it needs to grow. It currently is not approved as a breast cancer treatment. Torisel is an mTOR inhibitor. It works by blocking a protein called mTOR that helps cancer cells grow. Treatment given before surgery--called neoadjuvant therapy---allows researchers to see the effect that the treatment has on the tumor. This study is investigating the effect that the DAT regimen has when it is given before surgery to women with triple-negative breast cancer. To be eligible, patients must have stopped a neoadjuvant anthracycline-based regimen because the cancer progressed or they experienced too many side effects to continue.
This is a Phase II trial

Chemotherapy With Microwave Thermotherapy Before Surgery

Randomized Pivotal Trial to Assess the Safety and Efficacy of Preoperative Focused Microwave Thermotherapy Plus Preoperative Chemotherapy Versus Preoperative Chemotherapy Alone for Cytoreduction of Large Breast Cancer in... (NCT01204801)

Summary

Large tumors are sometimes treated with chemotherapy prior to surgery (neoadjuvant treatment) in order to reduce the tumor's size. If the tumor does shrink, the surgeon may be able to perform a lumpectomy instead of a mastectomy. Studies have shown that cancer cells are sensitive to microwave-generated heat, and that using microwave-generated heat therapy prior to surgery can help shrink tumor size. The purpose of this study is to determine whether neoadjuvant treatment that combines focused microwave heat treatment and chemotherapy is more effective than neoadjuvant chemotherapy alone for shrinking large breast tumors.
This is a Phase III trial

Doxil + Paraplatin Followed by Surgery & Taxol in Stage II-III Triple Negative Tumors

A Phase 2 Trial of Liposomal Doxorubicin and Carboplatin in Patients With ER, PR, HER2 Negative Breast Cancer (TNBC) (NCT02315196)

Summary

Pegylated liposomal doxorubicin (Doxil®) and Carboplatin (Paraplatin®) are chemotherapy drugs used to treat breast cancer. Paclitaxel (Taxol®) is another chemotherapy drug used to treat breast cancer. In this study, Doxil and Paraplatin will be given before surgery. This will allow the researchers to see how well the combination shrinks the tumor. After surgery, patients will receive the drug Taxol. This will allow the researchers to see how well the three drugs work together to reduce the size of the original tumor and reduce the risk of recurrence in women with stage II-III triple-negative breast cancer.
This is a Phase II trial

Paraplatin and Taxotere Before Surgery for Stage I-III Triple-Negative Breast Cancer

CADENCE: Carboplatin and Docetaxel in Neoadjuvant Treatment of ER-Negative, HER2-Negative Breast Cancer: A Co-Clinical Trial With Genoproteomic Discovery (NCT02547987)

Summary

Carboplatin (Paraplatin®) is the only platinum-based chemotherapy drug used to treat breast cancer. It is currently used to treat advanced breast cancer. Previous studies have suggested it may be effective against stage I-III, triple-negative breast cancer. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat breast cancer. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to see how the drug effects the breast tumor. This study is evaluating the safety and effectiveness of using Paraplatin and Taxotere before surgery to treat stage I-III triple-negative breast cancer.
This is a Phase II trial

Neoadjuvant Metronomic Chemotherapy for Stage II-III Triple Negative Breast Cancer

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer (NCT00542191)

Summary

Metronomic chemotherapy is new approach to treatment that involves giving very low doses of chemotherapy over a longer period of time. There is evidence that metronomic chemotherapy can slow tumor blood vessel growth and produce fewer side effects than standard high-dose chemotherapy. Research has also shown it to be effective in tumors that have not responded to standard treatment. Given the limited options available for women with hormone-negative and HER2-negative breast cancer, researchers are studying the effectiveness of metronomic chemotherapy before surgery in women with triple-negative disease.
This is a Phase II trial

Dose-Dense ACT Chemo without Neulasta for Early Stage Breast Cancer

Feasibility and Safety of Avoiding Granulocyte Colony-stimulating Factor Prophylaxis During the Paclitaxel Portion of Dose Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen (NCT02698891)

Summary

If you receive chemotherapy, you may develop an infection. Pegfilgrastim (Neulasta®) is given to reduce this risk. ACT (doxorubicin/Adriamycin®, cyclophosphamide/Cytoxan® and paclitaxel/Taxol®) are three chemotherapy drugs often used together to treat breast cancer. Researchers think it may be possible to give ACT without Neulasta during the Taxol portion to avoid its side effects, including bone pain. In this study, you will receive dose-dense Taxol after finishing dose-dense AC and only get Neuslasta if you begin to develop a fever with infection and low blood counts or need to delay Taxol due to low blood counts. To take part, you may be at any point during AC treatment, but have not yet started Taxol treatment. </p> In this study, you will receive dose-dense chemotherapy. This means you will have chemotherapy treatments that are scheduled closer together, such as every 2 weeks apart instead of every 3 weeks.
This is a Phase II trial

Cisplatin vs. AC Before Surgery in Patients w/ a BRCA Mutation

A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations (NCT01670500)

Summary

Women and men who are born with a BRCA1 or BRCA2 genetic mutation are at increased risk of developing breast cancer. Cisplatin is a platinum-containing chemotherapy drug that is used alone or in combination with other drugs to treat ovarian, bladder, and testicular cancers; it is sometimes used to treat other types of cancer as well. It is not FDA approved to treat breast cancer. Doxorubicin (Adriamycin®) and cyclophosphamide--known as AC--is routinely used to treat breast cancer. Giving chemotherapy in the neoadjuvant (before surgery) setting allows researchers to study how the tumor responds to the treatment regimen. It can also shrink the tumor, potentially allowing a patient to have a lumpectomy instead of a mastectomy. This study is comparing cisplatin to AC in BRCA+ women and men with newly diagnosed breast cancer.
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

Ipatasertib and Taxol Before Surgery for Early-Stage Triple-Negative Breast Cancer

A PHASE II RANDOMIZED, DOUBLE-BLIND, STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR TO AKT, IN COMBINATION WITH PACLITAXEL AS NEOADJUVANT TREATMENT FOR PATIENTS WITH EARLY STAGE TRIPLE NEGATIVE BREAST CANCER (NCT02301988)

Summary

Scientists are trying to develop new drugs that will be effective for patients with triple-negative breast cancer. Giving treatment before surgery, called neoadjuvant therapy, allows researchers to study the effect that the treatment has on cancer cells. Ipatasertib (GDC-0068) is a new type of targeted cancer therapy called an AKt inhibitor. It blocks a pathway inside the cell that regulates the cell's growth and survival. Early studies suggest that ipatasertib may be effective in patients with triple-negative breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug that is used to treat breast cancer. This study is comparing the effectiveness of Taxol and ipatasertib to Taxol and a placebo when it is given before surgery to patients with early-stage triple-negative breast cancer.
This is a Phase II trial

Treatment and Tissue Collection Before Surgery in Patients With Stage II-III Breast Cancer

Prospective Tissue Collection in Breast Cancer Patients Receiving Preoperative Systemic Therapy (NCT01897441)

Summary

Giving treatment before surgery—called neoadjuvant therapy—allows researchers to study the effect that the cancer drugs have on the breast tumor. Collecting and storing samples of tissue from breast cancer patients for laboratory research may help scientists learn which tumors respond best to certain treatments. This trial is collecting and storing tissue from patients with stage II-III breast cancer who have been given one of three different treatment combinations prior to surgery.

Chemo After Neoaduvant Chemo and Surgery for Basal-Like Triple-Negative Breast Cancer

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Observation in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy (NCT02445391)

Summary

Most triple-negative breast cancers have basal-like qualities, meaning the cells resemble the basal cells that line the breast ducts. Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink the tumor before surgery. Sometimes the tumor will disappear completely. In other instances, the tumor can be seen during surgery. Cisplatin (Platinol®) and carboplatin (Paraplatin®) are platinum-based chemotherapy drugs that laboratory studies suggest may be effective against basal-like triple-negative breast cancer. This study will investigate whether giving one of these chemotherapy drugs after surgery reduces the risk of recurrence in patients with basal-like triple negative breast cancer who had neoadjuvant therapy that did not make their tumor disappear. Participants will have their tumor specimens tested for basal-like qualities.
This is a Phase III trial

Propranolol & Chemo Before Surgery for Stage I-II Breast Cancer

A Phase II Study of the Beta-blocker Propranolol Alone and With Chemotherapy in Patients Receiving Neoadjuvant Treatment for Newly Diagnosed Breast Cancer (NCT01847001)

Summary

Propranolol (inderal®) is an FDA-approved drug used to treat high blood pressure, heart failure, angina, anxiety, and migraine. Laboratory studies suggest that Inderal also blocks the growth of the blood vessels cancer cells need to survive. Giving chemotherapy before surgery (neoadjuvant therapy) allows researchers to study how cancer cells respond to a treatment. This study is exploring the effectiveness of and side effects associated with giving Inderal along with neoadjuvant chemotherapy to treat stage I or II breast cancer. To be eligible, a woman must be receiving AC (adriamycin and cyclophosphamide) or paclitaxel (Taxol®) with or without Trastuzumab (Herceptin®) chemotherapy before surgery.
This is a Phase II trial

Dietary Intervention plus Chemotherapy Before Surgery for Early Stage Breast Cancer

CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer (NCT02827370)

Summary

To take part in this study, you must have been diagnosed with early stage breast cancer but not yet had surgery. This study is looking at whether a dietary intervention that will be determined based on your tumor's genomic characteristics changes the effect that chemotherapy given before surgery has on your cancer cells. Giving chemotherapy before surgery, called neoadjuvant treatment, allows researchers to study the effect a treatment had on the cancer cells after the tumor has been removed. Your tumor's genomic characteristics will be analyzed at the beginning of the study and after you have surgery.

Cisplatin vs. Paclitaxel Before Surgery for Triple Negative Breast Cancer

A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients With Triple Negative Breast Cancer Without Germline BRCA Mutations: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker (NCT01982448)

Summary

Researchers are trying to determine the best drugs for treating triple negative breast cancer. Giving treatment before surgery, called neoadjuvant therapy, allows researchers to study the effect that cancer drugs have on tumor cells. Cisplatin (Platinol®) is a chemotherapy drug used to treat other types of cancers that laboratory studies suggest may be effective against triple negative breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug that is routinely used to treat breast cancer. The HRD (Homologous Recombination Deficiency) assay is a tumor test that researchers think can predict if the tumor will respond to a specific type of chemotherapy. This study is comparing the effect that Platinol and and Taxol have on triple negative breast tumors when it is given before surgery. The study is also looking at whether the HRD assay can predict if the tumor will respond to the treatment.
This is a Phase II trial

Cisplatin & Radiation After Surgery for Triple Negative BC

A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer (NCT01674842)

Summary

New treatments for triple negative breast cancer are needed. Researchers believe that giving chemotherapy at the same time as radiation therapy to treat breast cancer may be more effective than using these treatments sequentially (one after another). Other types of cancers are currently treated this way. Cisplatin is a chemotherapy drug that works by preventing cancer cells from dividing and growing. It is not routinely used to treat breast cancer, but some studies suggest it may be particularly effective against triple negative tumors. Radiation is used to kill cancer cells that may have not been removed during surgery. The goal of this trial is to assess the safety, tolerability, and maximum tolerated dose of cisplatin when given at the same time as radiation to patients with triple negative breast cancer who have had or are planning to have a lumpectomy (breast conserving surgery).
This is a Phase I trial

Surgery

A New Way to Assess Tumor Margins During Surgery

A Phase 0/1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subject Undergoing Breast Cancer Surgery (NCT01796041)

Summary

Studies suggest that up to 70 percent of women who choose to have a lumpectomy need a second operation (a re-excision) because the initial surgery did not result in a clean margin--an area around the tumor that is cancer-free. Currently surgeons feel the breast tissue to determine whether they have obtained a clean margin. This trial is looking at whether an imaging technique that can be performed during surgery makes it easier to identify tumor margins and decreases the need for a second operation. To be eligible, participants must be planning on having a lumpectomy.
This is a Phase O trial

Cryoablation (Freezing) Instead of Surgery & Radiation for Older Women with Small Tumors

Freezing Alone Instead of Resection and Radiotherapy Of Small Breast Tumors: A Study of Cryoablation in the Management of Prognostically Favorable Early Stage Breast Cancer in Elderly Women (NCT01992250)

Summary

Cryoablation uses extreme cold to destroy cancerous tumors. The procedure involves using an ultrasound to pass a thin metal probe through the center of the tumor and then cooling the probe to an extremely low temperatures (-276°F) to freeze and kill the breast tumor. The procedure does not leave any significant scarring. The researchers believe that cryoablation can successfully destroy a small tumor (no greater than 2.0 cm). This study is looking at how well cryoablation works to prevent local recurrence in women 70 and older who would have otherwise had surgery and radiation to treat an early-stage invasive breast cancer. To be eligible for this study, a woman must have a tumor that is classified as Luminal A on a core needle biopsy.
This is a Phase II-III trial

Regional Anesthesia and Breast Cancer Recurrence

Regional Anesthesia and Breast Cancer Recurrence (NCT00418457)

Summary

Surgery is the primary and most effective breast cancer treatment. The goal of surgery is to remove all of the cancer. However, scattered micrometastases and/or a few tumor cells are almost always missed. While a variety of factors determine whether a woman will go on to have a breast cancer recurrence, recent animal and human studies suggest that replacing general anesthesia/analgesia with regional anesthesia/analgesia results in a lower incidence of breast cancer metastases. This trial will help determine whether the risk of recurrence differs between women who receive regional anesthesia/analgesia compared to those who receive general anesthesia/analgesia.
This is a Phase III trial

Lymph Node Dissection & Radiation after Neoadjuvant Therapy to Treat Positive Node(s)

A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy (NCT01901094)

Summary

Researchers are studying the best way to treat women who have received neoadjuvant therapy (treatment given before surgery) and are found to have a positive sentinel node(s) during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery. Axillary lymph node dissection (ALND) removes tumor cells that have spread to nearby lymph nodes or other nodes in the axillary (armpit) area. This study is comparing the effectiveness of ALND plus radiation therapy to radiation therapy alone in treating women who had neoadjuvant treatment and were found to have a positive sentinel node(s) during surgery.
This is a Phase III trial

Surgery: Reconstruction

Comparing Two Types of Tissue Expanders for Breast Reconstruction

Randomized Clinical Trial Comparing 1-Port and 2-Port Tissue Expanders for Breast Reconstruction (NCT02725801)

Summary

During breast reconstruction, a tissue expander is put into the chest wall. The expander is filled with saline (salt water) through a port to gradually stretch the skin and make space for the implant. The traditional type of expander has one port. AlloX2® is a new type of expander that has two ports: one port fills the expander and the other drains seroma, the clear bodily fluids that develops where the breast has been removed. In this study, half of the women will receive the regular one-port expander and the other half will receive the two-port expander. This will allow the researcher to see whether women have a better outcome or less complications when using a one-port or two-port expander. To be eligible, a woman must be planning to have immediate tissue expander breast reconstruction following her mastectomy.

Radiation oncology

Proton vs. Photon Radiotherapy for DCIS or Stage I-III Breast Cancer

Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341)

Summary

Photon radiation therapy is the standard X-ray radiation therapy used to treat breast cancer. Proton radiation therapy is a type of radiation treatment that delivers radiation more directly to the cancer cells, making it less likely to damage nearby normal tissues. It is often used to treat brain tumors. This study is comparing the side effects and effectiveness of photon radiation to proton radiation when it is used to treat DCIS or stage I-III breast cancer. To be eligible, a patient must be between the ages of 21 and 65 and have had a lumpectomy or a mastectomy.
This is a Phase III trial

Partial Breast Radiation After Lumpectomy in Women 50 & Older with Stage I Breast Cancer

Prone Partial Breast Irradiation (PBI): Prospective Randomized Controlled Non-inferiority Trial to Compare Radiation Fibrosis With Five Versus Three Fractions (NCT02755896)

Summary

During partial breast irradiation (PBI), the radiation beam is directed to the area of the breast where the cancer was removed. Radiation fibrosis—the hardening of breast tissue—is one side effect of radiation therapy. This fibrosis can cause ongoing discomfort. This study is comparing the effectiveness and side effects (including the development of fibrosis) of two different schedules and doses of PBI therapy in women age 50 and older with stage I breast cancer. To be eligible, a woman must be postmenopausal and have had a lumpectomy.
This is a Phase II trial

Intraoperative Radiation for Age 45 and Over with Early Stage Breast Cancer

A Prospective Single-Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early-Stage Breast Cancer (NCT02400658)

Summary

Breast conserving surgery (lumpectomy) followed by radiation therapy is a standard treatment for early-stage breast cancer. Intraoperative radiation therapy (IORT) delivers a high dose of radiation guided by CT-imaging during surgery to the area in the breast where the tumor was removed. This study is evaluating the effectiveness of IORT in women with early-stage breast cancer who are age 45 or older and have a tumor less than or equal to 3cm.
This is a Phase II trial

A Radiation Boost Before Surgery for DCIS and Early Stage Breast Cancer

A Phase II Study of Preoperative Boost Radiotherapy in Patients With Breast With Biomarker Analysis (NCT02482389)

Summary

To take part in this study, you must have been recently diagnosed with DCIS or early stage breast cancer and scheduled to have surgery. Researchers think that a "boost" of radiation to the tumor before surgery will make the tumor smaller. A smaller tumor is easier to remove. Giving radiation before surgery also allows the researchers to study the effect radiation has on cancer cells. A radiation "boost" delivers radiation directly to the tumor.
This is a Phase II trial

Four Weeks of Radiation After Surgery for Breast Cancer That Has Spread to Lymph Nodes

Hypofractionated, Comprehensive Radiation Therapy for Node-Positive Breast Cancer (NCT02700386)

Summary

To take part in this study, you must have healed from your breast cancer surgery (lumpectomy or mastectomy). Also, cancer cells must have been found in your lymph nodes. Radiation treatment after breast cancer surgery is typically given daily for 6 weeks. In this study, researchers are giving patients larger doses of radiation daily for 4 weeks to see if this method works as well as 6 weeks at a lower dose.
This is a Phase II trial

Cosmetic Results of Lumpectomy & Hypofractionated Radiation

Phase II Evaluation of Hypofractionated Breast Irradiation in Patients Undergoing Standard Lumpectomy or Oncolytic Mammoplasty With Bilateral Breast Reduction (NCT01400399)

Summary

Breast conservation surgery followed by radiation therapy is an established treatment for early stage breast cancer. Breast conservation surgery refers to either lumpectomy, or bilateral reduction mammoplasty (BRM). Lumpectomy involves removal of the tumor with a small amount of surrounding normal tissue. With BRM, a larger margin of normal tissue around the tumor is removed and the opposite breast is surgically reduced in size to maintain symmetry. All women in this study will have either lumpectomy or BRM followed by approximately 3 weeks of radiation treatment (hypofractionated). This data collection trial will evaluate the cosmetic outcome and factors contributing to cosmetic outcome in women treated with lumpectomy or BRM followed by hypofractionated radiation (larger doses (fractions) of radiation in fewer sessions over a shorter period of time). To be eligible participants must be at least 50 years old, diagnosed with DCIS or early stage breast cancer, with no lymph node involvement.

Internal Breast Radiation Therapy for Early-Stage Disease

A Natural History Study of Patients Receiving High Dose Rate Brachytherapy (NCT00924027) (NCT00924027)

Summary

Women with ductal carcinoma in situ (DCIS) and early-stage breast cancer are often treated with a lumpectomy (breast conserving surgery) followed by radiation therapy. Brachytherapy is a type of radiation treatment that delivers a high dose of radiation directly to the tumor area. Brachytherapy is delivered through small radioactive "seeds" that are put into a hollow device that has been placed inside the area of the breast where the DCIS or tumor was removed. Brachytherapy takes less time than traditional radiation therapy. It also reduces the amount of radiation healthy tissue receives. The goal of this study is to evaluate the quality of the brachytherapy procedure being used to treat women with DCIS or early-stage breast cancer at the National Institutes of Health's Radiation Oncology Branch.
This is a Phase II trial

Radiation Therapy During Surgery for Early-Stage Disease

Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT) (NCT01295723)

Summary

Radiation therapy is used following a lumpectomy to destroy any cancer cells that may be left in the breast after surgery. It usually consists of 3-5 weeks of daily whole breast radiation therapy, followed by a “boost” of 5-8 daily radiation treatments targeted directly to the site where the tumor was located. Intraoperative radiation therapy with electrons (IOERT) is a new technique that gives intensive radiation therapy during surgery to the area where the tumor was removed. The purpose of this study is to evaluate the safety and effectiveness of using IOERT in individuals with Stage I or II breast cancer who go on to receive three weeks of whole breast radiation therapy. To be eligible, participants must be planning to have a lumpectomy.

Cyberknife Radiation After Surgery for DCIS or Stage I-II Breast Cancer

Phase I Dose Escalation Trial of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation (SB-PBI) For Early Stage Breast Cancer (NCT02685332)

Summary

To take part in this study, you must have been diagnosed with DCIS (ductal carcinoma in situ) or some early stage (stage I or II) breast cancer. You must also have had a lumpectomy (breast conserving surgery) and be planning on having radiation. Radiation is used after surgery to kill any breast cancer cells that may be left in the breast. This study will help researchers learn whether it is safe to use a type of radiation called Cyberknife® to treat breast cancer. The study will also help researchers learn the best dose of Cyberknife radiation to use. Cyberknife radiation is a type of radiation treatment that delivers a high dose of radiation over a short period of time to a targeted area.
This is a Phase I trial

Radiation Treatment During Surgery for DCIS, LCIS and Stage I-II Breast Cancer

Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer (NCT02266602)

Summary

Radiation treatments have typically been given after breast cancer surgery. A newer type of treatment allows radiation to be given during surgery. Intraoperative radiation therapy (IORT) delivers a high dose of radiation to the inside of the breast, where the tumor was removed. This study is looking at the effectiveness of using IORT during breast conserving surgery (lumpectomy). To be eligible, you must have DCIS, LCIS or stage I-II breast cancer and not have received chemotherapy before surgery.

Proton Radiation Therapy After Mastectomy

Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy (NCT01340495)

Summary

Radiation is sometimes given after a mastectomy to destroy any cancer cells that may have been left behind during surgery. This study is looking at a new type of radiation therapy called proton radiation. By delivering radiation more precisely, proton radiation is expected to reduce side effects as well as decrease the amount of radiation exposure to nearby healthy tissue. To be eligible, participants must have received a complete mastectomy and have been recommended to receive radiation therapy.

Nipple and Areola Radiation After Nipple-Sparing Mastectomy

A Phase I Trial Assessing the Safety and Feasibility of Prophylactic Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Immediate Reconstruction in Patients With In-Situ or Invasive Breast Cancer (NCT01208974)

Summary

In a nipple-sparing mastectomy all of the breast tissue is removed during surgery, except for the nipple and areola. Researchers believe that administering radiation therapy to the nipple and areola after a nipple-sparing mastectomy can reduce a patient's risk of having a breast cancer recurrence. The goal of this trial is to determine the effectiveness, toxicity, and cosmetic outcome of radiation to the nipple and areola in patients who are having a nipple-sparing mastectomy. The researchers will also be determining the radiation dose that should be used in future studies.
This is a Phase I trial

Single Fraction Intraoperative Radiotherapy

Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial (NCT01688388)

Summary

The standard treatment for early stage breast cancer is breast conserving surgery (lumpectomy) followed by breast radiation. The radiation treatment is typically given over three to five weeks followed by between five and eight daily radiation treatments that are focused on the site where the lump was removed. Researchers believe that giving this full radiation treatment during surgery may be equally effective. This study is evaluating the safety and effectiveness of giving this single dose of radiation during breast cancer surgery.
This is a Phase I-II trial

Proton Beam Partial Breast Radiation for Early Stage Disease

Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation (NCT01245712)

Summary

The standard treatment for early stage breast cancer is a lumpectomy followed by radiation to kill any cancer cells that may still remain in the breast. Radiation therapy is usually given 5 days a week for up to 7 weeks. Proton-beam partial breast irradiation (PBI) is a newer type of radiation therapy. It is given over a shorter time period, and it directs the radiation to the precise area of the breast where the cancer was removed so that less healthy tissue is affected. The goal of this study is to find out if a 1-week course of proton-beam PBI causes fewer or less severe side effects (such as changes to the breast's appearance) than a longer course of radiation treatment. To be eligible, women must be planning to undergo radiation, and have had or are planning to have a lumpectomy.
This is a Phase II trial

Three New Radiation Options Following Lumpectomy or Mastectomy

Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial (NCT00909909)

Summary

Ductal carcinoma in situ (DCIS) and early-stage breast cancer are often treated with a lumpectomy followed by radiation. Post-lumpectomy radiation usually involves whole breast radiation (WBI), followed by a radiation “boost” targeted directly to the site where the DCIS or early-stage cancer was located. Individuals who receive a mastectomy may also, in some cases, receive radiation therapy as well. These standard radiation treatments are usually given five days a week for up to seven weeks. Accelerated hypofractionated radiation involves giving larger doses (fractions) of radiation in fewer sessions over a shorter period of time. The goal of this trial is to study the effectiveness and side effects associated with three different accelerated radiation treatments in women with DCIS or early-stage breast cancer who have had or will be having a lumpectomy or mastectomy.
This is a Phase II trial

Proton Radiation for Stage II-III Breast Cancer

Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Women With Stage III,Loco-Regional, Non-Metastatic Breast Cancer (NCT01758445)

Summary

Radiation is often used following surgery to treat breast cancer. Standard X-ray radiation uses particles called photons to kill tumor cells. Proton therapy is an alternative type of radiation therapy that uses particles called protons instead of photons. Studies suggest that proton radiation may result in fewer side effects than traditional X-ray radiation. The purpose of this trial is to study the long-term effects of proton radiotherapy in women with locally advanced breast cancer.
This is a Phase II trial

Intensity-Modulated Radiation Therapy After Lumpectomy

A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy (NCT01185132)

Summary

Women whose breast cancer is removed by lumpectomy almost always receive radiation after surgery. Intensity-modulated radiation therapy (IMRT) is a type of high-precision radiotherapy that delivers focused, high-dose radiation to the tumor, while reducing spread to the surrounding normal breast and lung tissue. The goal of this trial is to compare the effectiveness of intensity-modulated radiation therapy with standard radiation therapy. To be eligible, participants must have had or be planning to have a lumpectomy followed by radiation.
This is a Phase III trial

Radiation for Women with Stage I-III Disease Who Had Chemo Before Surgery

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant... (NCT01872975)

Summary

Chemotherapy given before surgery (neoadjuvant treatment) can kill cancer cells in the lymph nodes. This means a woman who is initially node positive may be node negative at the time of surgery. The standard of care for women with early-stage breast cancer who have a lumpectomy is whole-breast radiation. Women who have a mastectomy typically do not receive radiation. Giving radiation to the lymph nodes following a lumpectomy and giving radiation to the chest wall and lymph nodes following a mastectomy may be more effective in women who become node negative after neoadjuvant chemotherapy. This study is enrolling women whose lymph node status changed from positive to negative after neoaduvant chemotherapy to see if additional radiation after surgery will reduce the risk of recurrence.
This is a Phase III trial

Hormone therapy

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

Targeted therapy

BMN 673 Before Surgery for BRCA+ Patients with HER2-Negative Tumors

A Pilot Study of BMN673 as a Neoadjuvant Study in Patients With a Diagnosis of Invasive Breast Cancer and a Deleterious BRCA Mutation (NCT02282345)

Summary

Like normal cells, cancer cells replicate their DNA when they divide. The BRCA and PARP proteins help repair DNA that becomes damaged during cell division. In women with a BRCA mutation, cancer cells are unable to use the BRCA protein to repair damaged DNA and use the PARP protein instead. BMN 673 is a PARP inhibitor, a new type of cancer drug that kills cancer cells by blocking the PARP protein from fixing the damaged DNA. Giving therapy before surgery--called neoadjuvant treatment--allows researchers to study the effect that a cancer therapy has on the cancer cells. This study is evaluating the effect of BMN 673 when it is given before surgery to patients who have an inherited BRCA mutation and have tumors that are HER2-negative. To be eligible, a patient must have a breast tumor that is at least 1 cm in size.
This is a Phase II trial

Olaparib After Chemo for BRCA+ HER2-Negative Stage I-III Breast Cancer

A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With ... (NCT02032823)

Summary

Olaparib (Lynparza) is a new type of drug called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. In tumor cells in women with a BRCA mutation, blocking this enzyme can lead to cell death. In Dec. 2014, Lynparza was approved for treating advanced ovarian cancer in women with a BRCA mutation. Prior studies suggest breast cancer that develops in patients with a BRCA mutation will also respond to Lynparza. This study is comparing the safety and effectiveness of Lynparza to a placebo in women with a BRCA mutation who have had surgery and neoadjuvant or adjuvant chemotherapy to treat early-stage HER2-negative breast cancer.
This is a Phase III trial

Dasatinib Before Surgery for Women with Triple-Negative Breast Cancer

Window of Opportunity Study of Dasatinib in Operable Triple Negative Breast Cancers With Nuclear Epidermal Growth Factor Receptor (NCT02720185)

Summary

To take part in this study, you must be diagnosed with triple-negative breast cancer that can be removed by surgery. You must also have a tumor that is tested and found to be nuclear EGFR-positive. Giving treatment before surgery (called neoadjuvant treatment) allows researchers to study the effect the drug has on your cancer cells. If you enroll in this study, you will receive the drug dasatinib (Sprycel®) before receiving the standard of care treatment for triple-negative breast cancer. Sprycel is used to treat a type of leukemia. It is not yet known if it will also be an effective treatment for breast cancer.
This is a Phase II trial

Chemotherapy & Herceptin Before Surgery for Stage I-III Tumors

A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients With Breast Cancer (NCT01750073)

Summary

Giving chemotherapy before surgery may make the tumor smaller, reducing the amount of tissue that needs to be removed during surgery. It also allows researchers to study how tumors respond to certain drugs. Paclitaxel (Taxol®) and cyclophosphamide (Cytoxan®) are two chemotherapy drugs that are routinely used to treat breast cancer. Trastuzumab (Herceptin®) is a targeted therapy that is used to treat HER2-positive breast cancer. This trial is studying the effectiveness of, and the side effects that occur when, giving Taxol and Cytoxan to patients with stage I-III breast cancer. Patients with HER2+ tumors will also receive Herceptin prior to surgery, so that the researchers can study a three drug combination—Taxol, Cytoxan, and Herceptin.
This is a Phase II trial

Personalized Gene-Based Treatment For Triple Negative Breast Cancer

A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer: Hoosier Oncology Group BRE12-158 (NCT02101385)

Summary

Researchers are trying to determine the best treatment for triple negative breast cancer. DNA from tumor samples collected at the time of surgery may provide information about which breast cancer treatments will work best on a specific tumor. Participants will have their tumors analyzed for 12 biomarkers or pathways found in breast cancer cells. One group will receive treatment based on the results. The other women will receive the standard of care. This will allow the researchers to compare therapy designed for each individual's tumor to the standard of care. To be eligible, participants must have had (or are planning to have) chemotherapy followed by surgery for breast cancer.
This is a Phase II trial

Herceptin in HER2-Negative Stage II/III Breast Cancer w/ HER2+ Disseminated Tumor Cells

A Phase II Randomized Trial Evaluating the Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Bone Marrow Disseminated Tumor Cells (NCT01779050)

Summary

Breast cancer patients who are found to have tumor cells in their bone marrow (known as disseminated tumor cells or DTCs) are at greater risk of a recurrence than patients without DTCs. Trastuzumab (Herceptin®) is used to treat HER2-positive breast cancer. However, some patients with HER2-negative tumors may have HER2-positive DTCs and may benefit from Herceptin therapy. ACT (doxorubicin/adriamycin, cyclophosphamide and Taxol) is a chemotherapy regimen used to treat breast cancer. This trial is comparing the safety and effectiveness of using Herceptin with ACT to using ACT alone to treat patients with stage II-III HER2-negative breast cancer who have been shown to have HER2-positive DTCs in their bone marrow.
This is a Phase II trial

Digoxin in Newly Diagnosed Operable Breast Cancer

Digoxin as a Novel Inhibitor of Global Hypoxia Inducible Factor-1α (HIF-1α) Expression & Downstream Targets in Breast Cancer: DIG-HIF1 Pharmacodynamic Trial (NCT01763931)

Summary

Breast cancer cells grow in a low oxygen environment called hypoxia. The protein HIF-1 controls the amount of oxygen in the body's cells. Researchers think blocking HIF-1 may make it harder for breast cancer cells to grow. Digoxin is a drug that has been shown to block HIF-1 in lab studies. (It is currently used to help the heart work better and to control heart rate.) The purpose of this study is to learn what effects digoxin may have on breast tumors. This will be done by comparing tumor tissue from a woman's original biopsy with tumor tissue removed at the time of surgery, after she has been on digoxin for two weeks. The researchers will also compare biopsy and surgery tissue from women not given digoxin with that of the women who did take it.
This is a Phase II trial

Personalized Treatment Before Surgery: The I-SPY 2 Trial

I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) (NCT01042379)

Summary

Targeted therapy is an active area of breast cancer research in which treatment is tailored to an individual's tumor type. The goal of this trial is to determine whether standard chemotherapy can be made more effective by adding investigational drugs that target specific tumor characteristics. All treatment will be given prior to surgery (neoadjuvant therapy), enabling researchers to directly evaluate how well the tumor is responding. The information that researchers gain from each participant will be used to help decide which treatments should be given to women who join the trial at a later date. By designing the trial in this way, researchers will learn more quickly which investigational drugs will be most beneficial for women with certain tumor characteristics.
This is a Phase II trial

Vandetanib Before Surgery to Study Its Effect on Cancer Cells in Stage I-III Breast Tumors

A Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Effect of Vandetanib on Cellular Markers of Proliferation and Apoptosis in Invasive Breast Cancer (NCT01934335)

Summary

Giving treatment before surgery (called neoadjuvant therapy) allows researchers to study the effect that the treatment has on cancer cells. Vandetanib (Caprelsa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It is approved for treating thyroid cancer. Ki-67 is a protein in cells that increases as the cell prepares to divide into new cells. By measuring Ki67, researchers can learn how quickly the cancer calls are growing. This study is comparing the effect of Caprelsa and a placebo on Ki-67 (and other markers of tumor growth) when it is given before surgery to patients with stage I, II or III breast cancer. To be eligible, a patient must have had a core biopsy showing an invasive tumor and be scheduled to have surgery.
This is a Phase II trial

Vaccines and Immunotherapy

A Vaccine for Treating HER2-Negative Advanced Breast Cancer

A Phase I Trial of the Safety and Immunogenicity of a Multiple Antigen Vaccine (STEMVAC) in HER2 Negative Advanced Stage Breast Cancer Patients (NCT02157051)

Summary

Vaccines made from DNA from tumor cells may help the body build an effective immune response to the cancer. This study is looking at how cancer cells respond to a new vaccine called STEMVAC that is designed to target a protein on breast cancer stem cells that is resistant to chemotherapy. In this trial, researchers are studying the side effects and best dose of this vaccine for treating HER2-negative, advanced (stage III and IV) breast cancer.
This is a Phase I trial

A Vaccine for Women with Triple-Negative Tumors Treated with Chemo Before Surgery

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy (NCT02348320)

Summary

This study is investigating the safety and efficacy of a personalized Polyepitope DNA vaccine. A "personalized" vaccine is produced, in part, from a patient's own cancer cells. This increases the chance the vaccine will successfully stimulate the immune system to go after cancer cells. To be eligible, participants must have received chemotherapy prior to having surgery (called neoadjuvant chemotherapy) and still have some portion of the tumor remaining in the breast.
This is a Phase I trial

Breast Cancer Vaccine for Triple-Negative Breast Cancer Following Chemo Before Surgery

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy (NCT02427581)

Summary

A peptide is a naturally occurring biological molecule made up of amino acids. Researchers have developed a way to create a personalized synthetic long peptide vaccine that can generate an immune response to breast cancer cells by targeting mutations specific to a person's tumor. This study is investigating the side effects and best dose of this vaccine in patients with stage II-III triple-negative breast cancer who received chemotherapy before surgery and still have signs of the tumor in their breast.
This is a Phase I trial

Using Extreme Cold & Immunotherapy to Kill Cancer Cells Before Surgery

A Pilot Study of Pre-Operative, Single-Dose Ipilimumab, Nivolumab and Cryoablation in Early Stage/Resectable Breast Cancer(NCT02833233)

Summary

To take part in this study, you must have recently been diagnosed with early-stage breast cancer, have a tumor that is at least 1.5 cm or larger, and be scheduled to have surgery. Researchers think using extreme cold along with two immunotherapy drugs will make a breast tumor get smaller before surgery. Using extreme cold to kill cancer cells is called cryoablation. During the first part of the procedure, a very thin piece of metal, called a probe, is inserted into the tumor. During the second part, the probe is cooled to an extremely low temperature. This freezes and then kills cancer cells. Immunotherapy drugs help the immune system kill cancer cells. The two immunotherapy drugs used in this study are ipilimumab (Yervoy®) and nivolumab (Opdivo®).

Other treatment

Metformin and Antibiotics Before Surgery for DCIS & Early Stage Breast Cancer

A Phase II Study of Metformin in Combination With Doxycycline in Patients With Localized Breast and Uterine Cancer (NCT02874430)

Summary

To take part in this study, you must have recently been diagnosed with DCIS or early-stage breast cancer and is scheduled to have the tumor removed by surgery at Thomas Jefferson University Hospital in Pennsylvania between 1 to 6 weeks from the time of your enrollment in this study. Researchers believe combining metformin with doxycycline will be an effective cancer treatment. Metformin hydrochloride is a drug used to treat diabetes. Doxocycline is a commonly used antibiotic drug.
This is a Phase II trial

A Low-Calorie Diet During Radiation for DCIS or Stage I Tumors

A Feasibility Pilot Trial Evaluating Caloric Restriction for Oncology Research in Early Stage Breast Cancer Patients (NCT01819233)

Summary

Laboratory studies suggest that a low-calorie diet can keep cancer cells from getting the blood glucose they need to survive. A low-calorie diet may also make it easier for radiation therapy to kill cancer cells. This pilot study is investigating whether it is possible to conduct a clinical trial on the effectiveness of combining a low-calorie diet and radiation. This study will also help the researchers identify the best way to assess the effect of the low-calorie diet. To be eligible, participants must be female, diagnosed with DCIS or stage I breast cancer, and scheduled to have a lumpectomy followed by radiation.

Metformin & Atorvastatin Before Surgery to Study Their Effect on Cancer Cells

Pre-Surgical "Window of Opportunity" Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer (NCT01980823)

Summary

Studies suggest that drugs used to treat diabetes and high cholesterol may be effective breast cancer treatments. Metformin is a medication used to treat patients with diabetes. Atorvastatin is used to treat high cholesterol. By giving these drugs before surgery--called neoadjuvant treatment--researchers can study the effect that they have on breast cancer cell. This study will investigate the effect that Metformin and Atorvastin have on breast cancer cells in women who will be having surgery to treat DCIS or breast cancer.
This is a Phase O trial

Preventing Breast Cancer

Telapristone Before Mastectomy for High-Risk, DCIS or Stage I-II Breast Cancer

Intra-mammary Distribution of Transdermal Telapristone Versus Oral Telapristone: A Randomized Window Trial in Women Undergoing Mastectomy (NCT02314156)

Summary

Telapristone is an anti-progesterone drug. Laboratory studies have found telapristone can prevent tumors from growing. Telapristone can be given as a pill or absorbed into the skin through a patch. Researchers want to see if giving telapristone before surgery can help prevent breast cancer in premenopausal women. This study is comparing the effectiveness of a telapristone pill or patch to a placebo pill or patch for preventing breast cancer in high-risk women and reducing risk of recurrence in women with DCIS or stage I-II breast cancer. To be eligible, a woman must be premenopausal and scheduled to have a unilateral or bilateral mastectomy.
This is a Phase II trial

Diagnosing Breast Cancer

Using 3D Mammography to Evaluate Breast Tumors

Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions. (NCT01773850)

Summary

Tomosynthesis is an FDA-approved imaging technique that can create a 3-D image of the breast. It does not require as much breast compression during imaging, making it less painful than conventional mammography. Studies suggest it may also be more accurate than conventional mammography. The goal of this study is to see if radiologists can confidently and accurately identify breast tumors identified through conventional mammography with breast tomosynthesis. To be eligible, participants must have received a breast cancer diagnosis following a conventional mammogram and be scheduled to have a clinical surgical breast biopsy.

Axillary Ultrasound to Detect Cancer in the Lymph Nodes

A Prospective Randomized Trial of Sentinel Lymph Node Biopsy Versus no Additional Staging in Patients With Clinical T-1-T2 N0 M0 Invasive Breast Cancer and Negative Axillary Ultrasound (NCT01821768)

Summary

During a lumpectomy, the standard of care is for the surgeon to perform a sentinel lymph node biopsy (SLNB). This procedure involves identifying, removing, and examining the sentinel node--the first lymph node under the arm to which the cancer cells are most likely to have spread. Ultrasound uses high-frequency sound waves to produce images. Studies suggest that axillary ultrasound (AUS)—images of the underarm area—may be as good as SLNB for determining whether the cancer has spread to the lymph nodes. In this study, half of the women will receive AUS. The other half will receive AUS and SLNB. This will allow the researchers to determine if AUS is as effective as SLNB. To be eligible for this trial, the patient must have a tumor less that 5 cm., no palpable nodes, and no evidence of metastatic disease. (A palpable node is one that doctors can feel with their fingertips.)

A Study of a New Type of Dye for Use During a Sentinel Lymph Node Biopsy

A Phase I/II Study of VST-1001 (Dilute Fluorescein) for Lymphatic Mapping and Localization of Lymph Nodes Draining a Primary Tumor Site in Patients With Clinically Node Negative Breast Cancer (NCT02294565)

Summary

Breast cancer surgery typically includes a sentinel lymph node (SLN) biopsy. The SLN is the first lymph node the cancer cells will spread to. A biopsy of the SLN allows the surgeon to see if the tumor may have spread. A special dye is used during breast cancer surgery to identify the sentinel node. VST-1001 is a new type of dye that can be used during a SLN biopsy. This study will determine the best dose of VST-1001 needed for a surgeon to identify the sentinel node. It will also determine how effective VST-1001 is when combined with the radiotracer used to determine which additional nodes should be removed. To be eligible, a woman must be clinically node-negative—have no enlarged nodes detected by her doctor.
This is a Phase I-II trial

Support/Education

Stress Management Program for Latina Survivors in Three Rural California Areas

Translating a Stress Management Program for Latinas (NCT02931552)

Summary

To take part in this study, you must identify as Latina and have been diagnosed with DCIS (ductal carcinoma in situ) or stage I-III breast cancer. You must also live in a rural area (Tulare, Santa Cruz or Imperial Valley County) in California, and be primarily Spanish-speaking, or Spanish monolingual. This study is investigating whether a community-based Stress Management Program called Nuevo Amanecer-II helps improve quality of life and reduce stress in Latinas living in rural areas in California. The stress management program is provided in-person by Compañeras (Companions), Latinas who have had breast cancer and have received training on ways to support others with breast cancer.

An Internet Program to Improve Communication Between Doctors and Cancer Patients

PatientCareAnywhere: Patient Support and Empowerment Across the Care Continuum (NCT02408406)

Summary

To take part in this study, you must be getting treated for breast cancer at City of Hope Medical Center in California. You must also have internet access at home. PatientCareAnywhere is an interactive internet (online) program that was designed to help patients communicate better with their doctors during their cancer treatment. This study will allow researchers to see if the program works better than traditional printed education materials.

Integrative Therapy Program to Prevent Lymphedema after Surgery

Prevention of Secondary Lymphedema by Utilizing Self-management Education in Conjunction With Acupuncture Among Breast Cancer Patients Who Are at High Risk of Developing Lymphedema (NCT02528539)

Summary

Lymphedema is a painful swelling in the arm, hand, or wrist caused by a build-up of lymph fluid. Women whose breast cancer surgery includes removing lymph nodes under the arm that contain cancer cells--called an axillary lymph node dissection--are at increased risk of developing lymphedema. Researchers have developed an integrative therapy program for lymphedema that includes acupuncture along with education on the benefits of a healthy diet, exercise, and lymphatic drainage techniques women can do on their own. This study is evaluating the feasibility and effectiveness of using this integrative therapy program to reduce the risk of lymphedema after breast cancer surgery. To be eligible, women must be newly diagnosed with stage I-III breast cancer and have had an axillary lymph node dissection within 4-6 weeks prior to enrollment.

Surveys/Interviews

BRCA Gene Mutations in Latinas with Breast Cancer

BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects (NCT01251900)

Summary

Some women who have triple negative (ER, PR, and HER2-negative) breast cancer also have a BRCA1 or BRCA2 genetic mutation. The number of Latinas with triple negative breast cancer who also have a BRCA1/2 mutation is not known. Learning more about BRCA1/2 mutation rates among Latinas will help researchers provide better treatment to this group of women. The purpose of this trial is to study DNA samples taken from saliva and the medical histories of Latinas who have been diagnosed with breast cancer. Participants can reside anywhere in the U.S.

  • Participation TimeSaliva sample and questionnaire by mail
  • No Visits Required for this TrialNo travel required 

Breast Cancer Registry to Learn More about Breast Cancer Patients & Their Families

Development and Implementation of The Breast Cancer Collaborative Registry (BCCR) (NCT00666731)

Summary

The Breast Cancer Collaborative Registry (BCCR) is a computerized database started by researchers to collect information about breast cancer patients and their families. The information is collected through surveys patents fill out online or on paper. Collecting this information may help breast cancer researchers learn more about what causes breast cancer to develop and what increases breast cancer risk.

Study of Relationship Between Oral/Gut Microbiomes and Breast Cancer

Role of the Oral and Gut Microbiomes in Breast Cancer (MAN001)

Summary

Bacteria found in our mouth and our guts may provide information about our overall health. This study is investigating whether bacteria in the mouth or gut have any relation to breast cancer. For the study, researchers will compare bacterial DNA from cheek and stool samples provided by women with breast cancer and healthy women. This study is open to women with DCIS and invasive breast cancer who will be starting treatment. It is also open to healthy women. Women who have been treated for a prior cancer or DCIS are not eligible. For breast cancer patients, the bacteria samples can be provided after surgery. However, they must be provided before starting chemotherapy, hormone therapy, targeted therapy or radiation.

The Health of Women Study: Learning About the Causes of and Ways to Prevent Breast Cancer

The Health of Women (HOW) Study (NCT02334085)

Summary

The Health of Women (HOW) study is an international online study for women and men with or without a history of breast cancer. Participants in this study complete questionnaires about their health, job, diet and family history, among other topics. The researchers will use the information collected from these questionnaires to gain insight into what causes breast cancer and how to prevent it. This study is open to all women and men of every age, ethnicity, sexual orientation and occupation.

A Study of the Inherited KRAS-Variant Mutation and Breast Cancer Risk

Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment (NCT02253251)

Summary

Researchers have identified an inherited genetic mutation—a KRAS-variant—that may increase a person's risk of developing breast or other types of cancer. This study will follow participants for 10 years in order to analyze the association between the KRAS-variant mutation and cancer risk. The researchers will also look at the effect that different lifestyle factors have on cancer risk. All participants will have a saliva sample tested for the KRAS-variant. To be eligible, participants must have a personal or family history of breast cancer.

Cancer Support Community Online Survey: The Cancer Experience Registry

Cancer Experience Registry: An Online Initiative to Change the Future of Cancer Care (NCT01295658)

Summary

Researchers are trying to develop programs that can successfully address the needs of people who have experienced breast cancer. The Cancer Experience Registry is an online survey designed to identify and understand the emotional and social needs of women and men who have had a breast cancer diagnosis. It is open to anybody who has been recently diagnosed or is undergoing treatment, living with metastatic disease or years past treatment. This project is sponsored by The Cancer Support Community, an international non-profit dedicated to providing support, education and hope to people affected by cancer.

  • Participation TimeOnline questionnaire
  • No Visits Required for this TrialNo travel required 

Personalized Navigation & Treatment Planning for Latinas Diagnosed with Breast Cancer

Patient Navigation and Tailored Treatment Planning in Latina Patients With Breast Cancer (NCT02483377)

Summary

Studies have found that Latinas face more obstacles than white women in accessing quality cancer care. As a result, Latinas have lower rates of cancer survival than women of other ethnic or racial groups. Patient navigation and tailored treatment planning offered in Spanish as well as English may help guide Latinas with breast cancer through the healthcare system, remove barriers to care, and provide ease of access to essential resources. This study is investigating whether patient navigation and tailored treatment planning improves the overall healthcare experience for Latinas with breast cancer. To be eligible, a woman must self-identify as Hispanic and be receiving care at the LAC+USC Medical Center.

Effect of Chemo & Hormone Therapy on Hair, Skin & Nails in Early-Stage Breast Cancer

A Prospective, Longitudinal Study of Chemotherapy-Induced Hair Changes and Alopecia, Skin Aging and Nail Changes in Women With Non-Metastatic Breast Cancer (NCT02530177)

Summary

This study is looking at the effect that chemotherapy and hormone therapy have on the skin, hair and nails of women with early-stage breast cancer. The researchers want to see if there are certain clinical factors or genetic markers that can help predict which women are most likely to develop skin, hair or nail problems. To be eligible, participants must be about to start treatment with chemotherapy or hormone therapy for stage 0-III breast cancer.

Using Telemedicine for Genetic Counseling for the BRCA1/2 Mutations

A Randomized Study Of TeleGenetics Versus Usual Care To Increase Access To Cancer Genetic Services(NCT02517554)

Summary

To take part, you must be at high risk for having the BRCA mutations that increase breast and ovarian cancer risk. You must also have insurance coverage for genetic testing. Telemedicine (telephone and videoconferencing) may provide a way to offer genetic counseling to women who do not have a genetic counselor in their area. This study will allow researchers to learn if using telemedicine to deliver genetic counseling works as well as in-person genetic counseling sessions.
This is a Phase O trial

A Study of Inflammatory Markers, Chemotherapy and Chemobrain

Inflammation-Induced CNS Glutamate During Breast Cancer Treatment (NCT02421978)

Summary

Chemotherapy often causes cognitive symptoms (chemobrain) that can continue for months to years after treatment has ended. Inflammation caused by chemotherapy may contribute to these cognitive problems. In this study, researchers will measure the level of inflammatory markers in the blood and the brain of breast cancer patients receiving chemotherapy, breast cancer patients not receiving chemotherapy, and healthy volunteers to better understand the link between chemobrain and chemotherapy.

An Online Support Community for Women 60 and Older Receiving Chemotherapy

Improving Support for Older Patients Receiving Neo/Adjuvant Chemotherapy for Breast Cancer Using a Novel Social Media Intervention (NCT02639208)

Summary

Not a lot is known about the side effects and experiences of breast cancer patients age 60 and older receiving chemotherapy. It is known that not having good social support can affect quality of life, mood, and outcomes of people with cancer. This research study will evaluate the level of support provided by PatientsLikeMe (PLM), an on-line community for breast cancer patients receiving chemotherapy. The study will also look at whether PLM helps doctors collect information on chemotherapy-related side effects. To be eligible, participants must be at least 60 years old and have not yet started chemotherapy.

MammaPrint Tumor Testing and Treatment Decisions in Women with Stage I-II Breast Cancer

Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry (NCT02670577)

Summary

To take part, you must have recently been diagnosed with stage I-II breast cancer and not yet had chemotherapy. MammaPrint is a genomic test that analyzes the genes inside your tumor. The analysis will tell you if your risk of having your tumor spread to other parts of your body (metastasize) is low or high. In this study, a piece of your tumor will be analyzed with the MammaPrint test. Your doctor will make his/her first treatment recommendation before you get the test results. After the doctor sees the results, she/he will make a second treatment recommendation. This will allow the researchers to see if the MammaPrint results influence your doctor's treatment recommendations. The researchers will also look at whether the MammaPrint test results influence your treatment decisions.

Learning Why Some Women Develop Lymphedema After Surgery and Others Do Not

A Prospective Surveillance Program for Assessment and Treatment of Breast Cancer-Related Lymphedema After Axillary Lymph Node Dissection(NCT02743858)

Summary

To take part in this study, you must have recently been diagnosed with stage I, II or III breast cancer. You must also be going to have breast cancer surgery that includes the removal of the lymph nodes under the arm near the breast that has cancer in it. This is called an axillary lymph node dissection. Lymphedema is a painful swelling of the hand, wrist and/or arm that can occur after breast cancer surgery. This study will help researchers learn why some women and not others develop lymphedema after breast cancer surgery that includes an axillary lymph node dissection.

Targeted Intraoperative Radiotherapy (TARGIT) Registry Trial

Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery (NCT01570998)

Summary

Radiation is used to kill any breast cancer cells that may not have been removed during surgery. Targeted intraoperative radiotherapy is delivered during surgery immediately after the tumor has been removed. This allows the radiation to accurately target the tissue surrounding the tumor, where the risk of recurrence is highest. It takes about 20-35 minutes to provide intraoperative radiotherapy. This study, the Targeted Intraoperative Radiotherapy Trial (TARGIT), will follow women who receive this type of radiation therapy for five years, allowing researchers to study its effectiveness and side effects. This registry trial is open to patients who are receiving a lumpectomy (breast conserving surgery) and who are considered to be at low risk of having a local recurrence. If indicated, participants will also receive whole breast radiation.
This is a Phase III-IV trial

A Cell Phone-Based Health Program for Black Women With Breast Cancer Who Live in Florida

Piloting the Acceptability of a Culturally Tailored Evidence-Based mHealth Intervention for Low-Income Black Women With Breast Cancer (NCT02463474)

Summary

To take part in this study, you must be a Black woman who was diagnosed with DCIS or stage I-III breast cancer in the past 6 months. You must be able to travel to the University of Florida Health Shands Hospital or HealthStreet in Florida. You must also have a cell phone that can receive text messages and video clips. This study will see whether having short videos about breast cancer sent to you on your cell phone helps you learn about breast cancer treatments and life after breast cancer. The study is open to Black women from any cultural background (African American, Caribbean Islander, Haitian, Black hispanic, and more).

Individualized Radiotherapy Education for Patients with Stage I-III Breast Cancer

Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer (NCT02366806)

Summary

The standard of care for treating early-stage breast cancer is a lumpectomy followed by radiation. Prior to starting radiation, patients typically receive general information about radiation therapy and its potential side effects. An in-depth, personalized treatment education plan may be more beneficial. This study will compare the benefits of a standard radiation education plan to a personalized radiation education plan in patients with early-stage breast cancer. To be eligible, a patient must be scheduled to receive radiation therapy for early-stage breast cancer at the University of California, Davis.

Studying Tumor-to-Breast Ratio in Patients with DCIS or Early-Stage Breast Cancer

A Prospective Trial to AssessTumor:Breast Ratio and Patient Satisfaction in Following Lumpectomy Versus Mastectomy With Reconstruction (NCT02216136)

Summary

The size of the tumor compared to the size of the breast is referred to as the tumor-to-breast volume ratio. The ratio is a factor in whether a woman has the option of having a lumpectomy. In this study, women who are scheduled to undergo lumpectomy, mastectomy, or mastectomy with immediate reconstruction for ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or early stage breast cancer will have a breast MRI that determines their tumor-to-breast volume ratio prior to surgery. After surgery, patients will complete questionnaires designed to assess their quality of life.

A Study of the Relationship Between Chemotherapy and Intestinal Bacteria and Weight Gain

Changes in Intestinal Microbiota in Association With Chemotherapy Treatment (NCT02370277)

Summary

Breast cancer patients who gain weight during or after their cancer treatment are at increased risk of having a breast cancer recurrence. Chemotherapy drugs may change the gut bacteria in ways that make patients prone to weight gain. Researchers can study the effect that chemotherapy has on gut bacteria by analyzing the bacterial composition in a patient's stool sample. In this study, patients will provide stool samples for analysis before and after neoadjuvant (before surgery) or adjuvant (after surgery) chemotherapy. To be eligible, patients must have been diagnosed with DCIS or early-stage breast cancer and scheduled to have surgery at the Norris Comprehensive Cancer Center or Los Angeles County/University of Southern California Medical Center.

Arm Strength & Range of Motion Before and After Breast Cancer Surgery

Breast Clinic Strength and Range of Motion Study (NCT00489125)

Summary

Breast cancer surgery can affect a woman's arm strength and her shoulder range of motion. It can also cause lymphedema, a painful swelling of the arm or hand. In this study, researchers will evaluate a woman's strength and range of motion before she has surgery and compare it to the strength and range of motion she has after surgery. This information will help the researchers learn more about how breast cancer surgery affects a woman's arm and shoulder. It will also help them identify better ways to provide care after surgery. To be eligible, participants must be planning to have their breast cancer surgery at the Comprehensive Cancer Center Breast Clinic at Wake Forest University Baptist Medical Center.

A Registry for Patients with a Breast Cancer Genetic Mutation or Triple Negative Tumor

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (NCT02302742)

Summary

Women and men who carry an inherited genetic mutation are at increased risk of developing breast cancer. BRCA1 and BRCA2 are the most common genetic mutations associated with breast cancer risk. But there are other mutations that also increase breast cancer risk, including PTEN, P53, PALB2, and others. Previous studies have found that individuals with triple-negative breast cancer are likely to carry the BRCA mutation. This registry study will collect cancer-related information from individuals with triple negative breast cancer and/or inherited genetic mutations. The information collected in the registry will be used to learn more about the relationship between genetic mutations and cancer outcomes in individuals with triple negative breast cancer.

Sexual and Reproductive Health Study

Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma (NCT01788839)

Summary

Cancer and its treatment may affect sexual and reproductive health. To help researchers learn more about the problems women face, participants in this study will complete questionnaires on sexuality and pregnancy before, during, and after cancer treatment. The information will be used to help doctors identify which women are most likely to have early menopause or develop sexual problems during cancer therapy, or have difficulty getting pregnant after cancer treatment. To be eligible for this study a woman must be age 50 or younger, newly diagnosed with breast cancer, and planning on having, or within one month of starting, chemotherapy.

A Positive Piggy Bank: A Mindfulness Program for Women Scheduled for Breast Cancer Surgery

A Pilot Study of a Brief Pre-Operative Intervention for Patients Undergoing Breast Surgery (NCT02939040)

Summary

To take part in this study, you must be scheduled to have surgery for stage I, II, or III breast cancer. The goal of this study is to determine if participating in a mindfulness program called "Positive Piggy Bank" improves well-being and reduces post-surgery symptoms. If you take part in the "Positive Piggy Bank" program, you will note at least one positive event that happens each day, write it down on a piece of paper, and deposit the piece of paper in a piggy bank. You will read all the notes in the piggy bank the night before your surgery.

The Young Women's Breast Cancer Study

Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study (NCT01468246)

Summary

Young women with breast cancer have unique needs and concerns. The goal of this study is to follow a large group of young women with breast cancer over time to learn more about the types of tumors they develop, the treatments they have, the side effects they experience, and the psychosocial concerns they face. The researchers are also interested in seeing if there is a relationship between tumor biology and patient outcome. To be eligible, participants must have been diagnosed with breast cancer at age 40 or younger.

Activities

Effect of Aerobic Exercise During and/or After Chemotherapy

Optimal Timing Trial: Randomized Trial of Supervised Aerobic Training During or After Adjuvant Therapy for Operable Breast Cancer (NCT01943695)

Summary

Taking part in an aerobic exercise program may help women who are being treated for breast cancer. In this study, researchers will see if women have fewer side effects if they exercise during chemotherapy, after they have completed chemotherapy, or during and after chemotherapy. To take part, you must have stage I-III HER2-negative breast cancer and have already had breast cancer surgery (lumpectomy or mastectomy).

Yoga for Breast Cancer Patients Undergoing Chemotherapy

A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms (NCT02360904)

Summary

Yoga is a mind-body intervention that has been shown to reduce fatigue and improve overall quality of life in breast cancer patients receiving chemotherapy. This study is comparing the effect that yoga has on quality of life when the classes are started immediately or three months after beginning chemotherapy. To be eligible, patients must be scheduled to receive chemotherapy or have been on chemotherapy for less than two weeks; not planning on starting yoga; and not have done yoga regularly within 3 months of enrolling in the study.

Yoga During Radiation Therapy

Biobehavioral Effects of Yoga for Women With Breast Cancer Undergoing Radiotherapy (NCT01202851)

Summary

Researchers believe that mind-body interventions can be beneficial to women undergoing breast cancer treatment. Yoga is a mind-body intervention that has been shown to reduce fatigue as well as improve quality of sleep, physical vitality, and overall quality of life in women being treated for breast cancer. This study will compare the effectiveness of a yoga program with a stretching/relaxation program for improving the physical and emotional well-being of women with DCIS or Stage I-III breast cancer who are undergoing radiation treatment after surgery. The study will also include a group of women who will not take part in either the yoga or stretching/relaxation program. To be eligible, participants must be planning to receive radiation therapy following breast surgery. In addition, participants must not have practiced yoga in the year prior to breast cancer diagnosis.
This is a Phase III trial

Exercise in Stage I-III Breast Cancer Patients (Age 65 and up) Receiving Radiation

Phase 2 Randomized Study of a Walking Intervention for Radiation-related Fatigue Among Breast Cancer Patients Receiving Adjuvant Radiation (NCT02434367)

Summary

Studies suggest that patients who exercise have less fatigue during radiation therapy. Walk with Ease (WWE) is a community-based walking program designed by the Arthritis Foundation. In this study, researchers will compare fatigue levels between breast cancer patients who take part in the WWE program and those who do not. The researchers will also analyze patients' blood samples in order to study the relationship between inflammatory biomarkers, exercise, and fatigue. To be eligible, patients must be 65 or older, scheduled to receive hypofractionated or standard fractionated radiation therapy to the breast or chest wall following surgery, and not currently be walking ≥120 minutes per week.
This is a Phase II trial

Massage to Reduce Anxiety Before Breast Cancer Surgery

Utility of Preoperative Massage in Breast Surgery Patients (NCT01667328)

Summary

It is not uncommon for patients to report feeling anxious prior to their breast cancer surgery. Studies have demonstrated that massage can offer some health benefits for people with cancer. Massage has also been found to be help reduce anxiety. This study is investigating whether breast cancer patients who receive massage therapy by a licensed massage therapist before surgery have lower anxiety levels than those who do not receive massage therapy.

Increasing Physical Activity During Chemotherapy for Early Stage Breast Cancer

A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer (NCT02159157)

Summary

Researchers have found that breast cancer survivors who are physically active are at lower risk of having a breast cancer recurrence. Recent studies suggest that taking part in physical activities during cancer treatment may also be beneficial. There are different ways to encourage breast cancer patients to become more active during their treatment. This study is comparing two approaches to increasing physical activity in breast cancer patients who are scheduled to begin chemotherapy. To be eligible, participants must be scheduled to begin treatment within 4 weeks.

Acupuncture to Reduce Side Effects in Breast Cancer Patients Receiving Taxol

Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients: A Pilot Study (NCT02364726)

Summary

Acupuncture is a traditional Chinese medical technique that involves inserting very thin needles into specific points on the body. Studies suggest it can help reduce certain types of pain. Paciltaxel (Taxol®) is a chemotherapy drug used to treat breast cancer. One of the side effects associated with Taxol is numbness, tingling, or burning pain in the hands or feet. (This side effect is called peripheral neuropathy.) Acupuncture may be able to reduce this pain. This study is investigating whether weekly acupuncture reduces pain in women who are receiving a chemotherapy regimen that includes weekly Taxol before or after surgery to treat stage I-III breast cancer.

Lifestyle Changes During Radiation Therapy to Improve Outcomes

The Role of Lifestyle Factors in Breast Cancer-Related Outcomes (NCT02079662)

Summary

Researchers are studying the effects that lifestyle has on the risk of a breast cancer recurrence, quality of life, physical functioning, hormone levels and immune function. This study is looking at the effect that a comprehensive lifestyle change program that addresses diet, exercise, and stress has on women with stage III breast cancer who are scheduled to have a 4 to 6-week course of radiation. To be eligible patients must have a body mass index (BMI) of 25 or higher. They must also not eat more than 3 servings of fruits/vegetables a day or exercise more than 75 minutes per week.

Exercise or Mind-Body Program Before Surgery

The Preoperative Health & Body Study (NCT01516190)

Summary

This study is designed to look at the changes that occur in women who take part in exercise and mind-body programs between their breast cancer diagnosis and breast surgery. The investigators are interested in seeing if these programs can decrease stress and anxiety and improve mood and quality of life during this time. The investigators are also interested in looking at whether this type of short program affects certain markers in breast cancer cells, such as their growth and death rates, or in blood hormones such as insulin, which have been linked to breast cancer development. To be eligible, participants must not be planning to receive chemotherapy or hormone therapy before surgery.

An Exercise Program to Improve Thinking and Memory in Women on an Aromatase Inhibitor

Influence of Exercise on Neurocognitive Function in Breast Cancer (NCT02793921)

Summary

To take part in this study, you must have had surgery for early-stage breast cancer and be planning to start on a type of anti-estrogen drug called an aromatase inhibitor. Problems with thinking, memory and other brain functions are a common side effect of the aromatase inhibitors. This study is investigating whether taking part in a supervised aerobic exercise program during the first 6 months you are on an aromatase inhibitor will help improve your thinking, memory, learning, attention and other brain functions. The aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®). All three are used to treat hormone-sensitive tumors in postmenopausal women.

Low-Calorie Diet To Reduce Side Effects of Chemotherapy

A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy (NCT01802346)

Summary

Chemotherapy drugs attack cells that are rapidly dividing, which is why they are an effective cancer treatment. However, other cells in the body that also divide rapidly, like those in the bone marrow, mouth, intestines, and hair follicles, are also likely to be affected by chemotherapy—which can lead to side effects. It is possible that eating a low-calorie diet may reduce chemotherapy-related side effects as well as improve how the tumor responds to treatment. This trial is investigating whether patients with early-stage breast cancer who eat a controlled low-calorie diet will have fewer side effects and a better response to chemotherapy than breast cancer patients who eat a normal diet. To be eligible, participants must be planning to receive chemotherapy treatment of AC (doxorubicin plus cyclophosphamide). (This trial also is enrolling men with prostate cancer.)
This is a Phase II trial

An Exercise Program for Early Stage Breast Cancer Patients (Age 65 and up) Starting Chemo

LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older (NCT02328313)

Summary

One biomarker for aging is p16. Studies have found that chemotherapy drugs used to treat breast cancer age the immune system and increase levels of p16. Breast tumors also make too much p16. The Walk With Ease Program is a community-based walking program developed by the Arthritis Foundation to help reduce pain and improve overall health. Researchers think a regular exercise regimen may lower the overexpression of p16 in women receiving chemotherapy. This study will investigate the effect the Walk With Ease Program has on p16 levels in women 65 years or older who have been diagnosed with early stage breast cancer. To be eligible, a woman must be scheduled to begin adjuvant or neoadjuvant chemotherapy.

An Exercise Program for Stage I - III Breast Cancer Patients Starting Chemotherapy

Impact of a Physical Activity Program on Biomarkers of Aging During Adjuvant or Neoadjuvant Chemotherapy for Breast Cancer (NCT02167932)

Summary

Studies have shown that blood levels of p16—a biomarker of aging— increase dramatically during chemotherapy. Studies also have shown that cancer patients who exercise have lower p16 levels than those who do not exercise. Researchers believe that patients who take part in physical activity during chemotherapy will not have their p16 levels increase at the same rate as those who do not exercise. Walk With Ease is a walking program developed by the Arthritis Foundation that has been shown to help reduce fatigue and pain. This study is looking at whether the Walk With Ease program has an effect on p16 levels in women between the ages of 21 to 59 who have been diagnosed with stage I - III breast cancer. To be eligible, women must be scheduled to receive chemotherapy before or after their breast cancer surgery.

Managing Side Effects

Zocor to Reduce Adriamycin-Related Heart Problems

Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin (NCT02096588)

Summary

Different types of chemotherapy drugs have different side effects. Anthracyclines, like doxorubicin (Adriamycin®), are a type of chemotherapy drug that may weaken the heart muscle. This heart damage can happen during or right after chemotherapy or it may occur many years later. The results of previous studies suggest that drugs used to lower cholesterol, called statins, may prevent anthracycline-related heart damage. Simvastatin (Zocor®) is an oral statin routinely used to lower cholesterol. This study is investigating whether women who take Zocor when receiving Adriamycin are less likely to experience heart damage than women who receive Adriamycin alone. To be eligible, a woman must be planning to receive the chemotherapy regimen AC (Adriamycin and Cyclophosphamide) before or after surgery.
This is a Phase II trial

Antibiotic to Prevent Memory Problems, Anxiety & Depression in Patients on Adriamycin

Randomized Placebo Controlled Study of Minocycline for Amelioration of Chemotherapy Induced Affective Disorders (NCT02203552)

Summary

Women who receive the chemotherapy drug doxorubicin (Adriamycin®) as part of their breast cancer treatment may develop problems with their memory and thinking skills, anxiety, and/or depression. Researchers think giving the drug Minocycline (Minocin) to women who are receiving Adriamycin may keep these side effects from developing. Minocin is is an antibiotic you take by mouth to treat infections. To take part, you must have stage I-III breast cancer and be scheduled to take Adriamycin before or after your breast cancer surgery.

Curcumin for Reducing Fatigue Related to Chemotherapy and Radiation Therapy

Randomized Phase II Study of Curcumin Versus Placebo for Inhibition of NF-kB DNA Binding in Peripheral Blood Mononuclear Cells of Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy (NCT01740323)

Summary

Fatigue is one of the most common side effect of radiation therapy. Previous studies have found that the NF-kB pathway appears to play a role in chemotherapy- and radiation-related inflammation and fatigue. Curcumin—an active component in turmeric—is a known inhibitor of the NF-kB protein. Researchers think decreasing the activity of NK-kB may reduce fatigue in women with breast cancer being treated with radiation. Meriva is a curcumin formula that is well absorbed by the body. In this study, researchers will compare the effectiveness of Meriva to a placebo for controlling cancer-related fatigue in women receiving whole-breast radiation. To be eligible, a woman must be scheduled to receive whole-breast radiation.
This is a Phase II trial

Melatonin to Reduce Fatigue Caused by Radiation Therapy

Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy: A Double Blind Placebo-Controlled Trial (NCT02332928)

Summary

Fatigue is a common side effect of radiation therapy. Melatonin is a hormone made naturally by the body that helps regulate sleep and wake cycles. Researchers think giving melatonin supplements to women before, during, and after their radiation therapy may help reduce fatigue. This study is comparing the effectiveness of melatonin supplements to a placebo in women receiving radiation as part of their breast cancer treatment.
This is a Phase III trial

Acupuncture for Women with AI-Related Joint Pain

Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain (NCT02548637)

Summary

Joint pain is one of the most common side effects associated with aromatase inhibitors (AIs)—anastrazole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®). Acupuncture is a traditional Chinese medical technique that involves inserting sterile, hair-thin needles into specific points on the skin to stimulate the nervous system. In this study, researchers will study the effect of acupuncture in women experiencing joint pain while on an AI. To be eligible, a woman must have been on an AI continuously for at least the preceding 2 months and not have had acupuncture treatment within 6 months of study enrollment.

Pain Coping Program for Managing Pain After Surgery in DCIS/Stage I-III Breast Cancer

Targeted Pain Coping Skills Training (PCST) for Prevention and Treatment of Persistent Post-Mastectomy Pain (NCT02439437)

Summary

Researchers have developed a Targeted Pain Coping Skills Training program women can take part in over the phone that may help reduce pain and stress after a mastectomy. This study is comparing this new phone-based skills training program to a program that gives patients printed educational materials. To take part, you must have ductal carcinoma in situ (DCIS) or stage I-III breast cancer, had breast surgery within the last 6 weeks, and have had a pain score of 3 or more during the first month following your breast cancer surgery. To be eligible, participants must receive cancer treatment in the Duke Health System.

Comparing Quality of Life After Chemo in Women Over & Under 65

Adjuvant Therapy in Older Versus Younger Women With Breast Cancer: Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life (NCT01030250)

Summary

Almost half of all new breast cancers diagnosed in the US are in women 65 years of age or older. Aging is associated with changes in physiology that can impact the toxicity and side effects associated with chemotherapy. More information is needed to determine whether treatment or dose recommendations should change as women grow older. More information is also needed about risk factors for toxicity other than age, such as the presence of other illnesses, nutritional status, cognitive functioning, and access to social support. The goal of this study is to learn more about and compare the toxicities and side effects experienced by women over and under age 65. Participants of any age are eligible for this study.

Counseling for Breast Cancer Patients Age 70 and Over

Pilot of a Geriatric Group Psychoeducational Intervention for Elderly Patients With Cancer (NCT00984321)

Summary

Many women seek counseling after a breast cancer diagnosis. This counseling program was developed to meet the specific needs of older cancer patients, who often find themselves facing problems related to both cancer and aging. The goal of this trial is to see whether a counseling program can help reduce depression, anxiety, and feelings of loneliness and isolation as well as improve the quality of life of older women with breast cancer. To be eligible, participants must be receiving treatment at Memorial Sloan-Kettering Cancer Center.

Using MRI to Monitor How Lymphedema Responds to Manual Lymphatic Drainage Therapy

Imaging Noninvasively With Functional-MRI for Onset, Response and Management of Lymphatic Impairment (NCT02611557)

Summary

Lymphedema--a painful swelling of the hand, wrist and/or arm--is a potential long-term side effect of breast cancer treatment. Manual lymphatic drainage (MLD) therapy uses light touch to move excess lymph and fluid out of the tissue and back into the lymphatic vessels. This study will use magnetic resonance imaging (MRI) to monitor how lymphedema responds to personalized MLD therapy in women who were diagnosed with DCIS or stage I-II breast cancer and are experiencing breast cancer treatment-related lymphedema.

SPI-2012 or Neulasta to Prevent Neutropenia in Patients Receiving Taxotere & Cytoxan Chemo

RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE) (NCT02643420)

Summary

Chemotherapy can cause neutropenia--a condition where a person has an abnormally low number of white blood cells. Patients who develop neutropenia are at increased risk of developing an infection. Docetaxel (Taxotere®) and cyclophosphamide (Cytoxan®)--known as TC chemotherapy--are routinely used to treat early-stage breast cancer. Neutropenia is a common side effect of TC chemotherapy. Pegfilgrastim (Neulasta®) is given along with chemotherapy to keep neutropenia from developing. SPI-2012 is a new drug designed to help the body make white blood cells. This study is comparing the effectiveness of SPI-2012 to Neulasta in individuals with early-stage breast cancer receiving TC chemotherapy. To be eligible, a patient must not have been treated previously with filgrastim, pegfilgrastim, or any other experimental drug to prevent neutropenia.
This is a Phase III trial

Acupuncture for Treating Chemotherapy-Induced Peripheral Neuropathy

Acupuncture for CIPN in Breast Cancer Patients (NCT02615678)

Summary

Peripheral neuropathy--pain, tingling, burning, or a numbness sensation in the hands and feet—is a common side effect of chemotherapy. Acupuncture is a traditional Chinese medicine technique that involves inserting sterile, hair-thin needles into specific points on the skin to stimulate the nervous system. This study will evaluate the effect that acupuncture treatments have on breast cancer patients who have developed peripheral neuropathy. To be eligible, patients must currently be receiving chemotherapy and have been experiencing symptoms for at least 1 month.

Ice Therapy (Cryotherapy) for Reducing Taxol-Induced Pain

Pilot Clinical Trial Evaluating the Utility of Topical Cryotherapy to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Controlled Trial (NCT02640053)

Summary

Ice therapy, or cryotherapy, uses an extremely cold liquid to freeze and destroy abnormal tissue. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. Paclitaxel (Taxol®) is a chemotherapy drug that is routinely used to treat breast cancer. Its side effects include peripheral neuropathy and similar types of aches and pains. Cryotherapy may be effective in reducing peripheral neuropathy and other pain caused by chemotherapy. This study is investigating whether individuals who receive cryotherapy along with Taxol experience less pain than those who receive Taxol alone. To be eligible, participants must be planning to be treated with Taxol and not have prior exposure to neurotoxic chemotherapy.

Impact of Lymphedema on Quality of Life After Breast Cancer

Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer. (NCT01521741)

Summary

Breast cancer treatments can result in long-term, painful swelling of the arm and hand, a condition called lymphedema. The goal of this study is to determine how the symptoms and functional disability that accompany lymphedema can impact breast cancer survivors' quality of life. To be eligible, participants must be planning to have surgery and receive follow-up care for breast cancer at Massachusetts General Hospital.

Topical Menthol Cream for Chemotherapy-Induced Neuropathy

Topical Menthol for CIPN: a Randomized, Placebo Controlled Phase II Trial (NCT01855607)

Summary

Peripheral neuropathy—nerve damage that causes pain or discomfort in the hands and feet—is a potential side effect of the taxane drugs used in many chemotherapy regimens. Menthol is often used in pain relieving balms, massage oils and liniments because it is cooling and anaesthetic when applied to the skin. This study is investigating whether a topical cream that contains menthol is more effective than a topical cream that does not contain menthol in reducing neuropathy-related pain in breast cancer patients. To be eligible, participants have completed Taxane-based breast cancer therapy within the last two years and have experienced neuropathy in the hands and feet frequently in the past seven days.
This is a Phase II trial

Lipitor for Preventing Chemotherapy-Related Heart Problems

Statin Therapy Operates to Prevent (STOP) Heart Disease in Breast Cancer Survivors Trial (NCT02674204)

Summary

Anthracyclines are a type of chemotherapy drug used to treat breast cancer. One potential side effect of these drugs is heart damage. Atoravastin (Lipitor®) is a drug used to lower cholesterol and reduce risk for heart disease. Researchers believe Lipitor may be able to reduce or eliminate the harmful effects anthracyclines have on heart tissue. This study will look at whether Lipitor is more effective than a placebo at reducing the heart damage caused by anthracyclines. To be eligible, participants must be newly diagnosed with stage I-III HER2-negative breast cancer and must be planning to start, or have completed one cycle of, a chemotherapy regimen that includes an anthracycline.
This is a Phase II trial

Metformin to Reduce Heart Problems Caused by Chemotherapy

A Phase II Pilot Study Using Metformin to Reduce Cardiac Toxicity in Breast Cancer Patients (NCT02472353)

Summary

Some chemotherapy drugs can damage the heart. Researchers think if you take the drug metformin while getting one of these chemotherapy drugs you will be less likely to have heart problems. Doxorubicin (Adriamycin®) is one of the chemotherapy drugs used to treat breast cancer that can cause heart problems. To take part in this study you must have early-stage breast cancer that is going to be treated with the chemotherapy drug Adriamycin. </p> Metformin is an oral drug used to control blood sugar in individuals with diabetes.
This is a Phase II trial

Nerve Block to Reduce Pain After Mastectomy & Reconstruction With a Tissue Expander

Does Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction Reduce Postoperative Pain and Opioid Requirement?: A Prospective Double-Blinded Randomized Controlled Trial (NCT02525718)

Summary

Pain is a common short-term and long-term side effect of breast reconstruction. Nerve blocks use medication to keep the nerves in a certain part of the body from feeling pain. Using a nerve block along with anesthesia (medicine to prevent pain) during reconstructive surgery may help reduce pain and the need for pain medication after surgery. This study will see if a nerve block is better than a salt-water injection for reducing pain in women having a mastectomy with immediate reconstruction with a tissue expander.
This is a Phase II trial

Detecting and Monitoring Lymphedema

Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report (NCT01544335)

Summary

Lymphedema is a painful swelling of the arm that can develop as a result of breast cancer treatment. Early detection and treatment of lymphedema may be able to help reduce or control this swelling. To improve early detection, better methods of measuring lymph fluid in the arm are needed. Bioimpedance spectroscopy involves using an extremely small electrical current to measure the amount of lymph fluid present in the arm. The goal of this study is to determine whether bioimpedance spectroscopy is as effective at detecting and monitoring lymphedema as a measurement device called a perometer. To be eligible, participants must be receiving follow-up care at Massachusetts General Hospital or the Dana-Farber/Harvard Cancer Center.

Health Education for Reducing Chemotherapy-Related Weight Gain

Taking Health Realization Into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors During Chemotherapy (NCT01941784)

Summary

Weight gain is a common side effect of chemotherapy treatment. The average patient gains about 5-8 pounds over a year. THRIVE (Taking Health Realization Into Valued Eating and Exercise) is a health education program that may help reduce weight gain and improve the quality of life of women undergoing chemotherapy. The goal of this study is to determine the effectiveness of the THRIVE project for preventing weight gain associated with chemotherapy treatments in women with newly diagnosed stage I-IV breast cancer who have recently started or are schedule to receive chemotherapy.

Reducing Post-Operative Pain From Breast Reconstruction

A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction (NCT02044302)

Summary

Opioids and sedatives like diazepam (valium) are the drugs typically used to manage pain in women who are having a mastectomy with breast reconstruction. Opioids are effective, but they can cause side effects like nausea, vomiting, sedation, and constipation. Bupivacaine is a local anesthetic. Botulinum toxin (commonly known as Botox) is a muscle relaxant. Both block the nerve impulses that send pain signals to the brain. This study is investigating whether using bupivacaine and Botox, either alone or together, during surgery will provide better pain control post-surgery and reduce incidences of opioid side effects in women who are having a mastectomy with breast reconstruction.
This is a Phase II trial

Reiki Therapy to Reduce Fatigue in Breast Cancer Patients On an Aromatase Inhibitor

Pilot Study on Energy Therapy or Massage to Reduce Fatigue in Breast and Prostate Cancer Patients on Hormone Therapy (NCT02758756)

Summary

To take part in this study, you must have stage I, II or III breast cancer, be on an aromatase inhibitor, and be experiencing extreme tiredness (fatigue). This study is investigating whether a type of touch therapy, called Reiki, can help reduce fatigue in breast cancer survivors who are taking an aromatase inhibitor. Reiki is a gentle touch therapy that its practitioners say helps promote healing and well-being by unblocking and balancing the flow of energy within the body.
This is a Phase I-II trial

Atrovastatin to Reduce Anthracycline-Related Heart Damage in Early Stage Breast Cancer

Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT) (NCT01988571)

Summary

Different types of chemotherapy drugs can have different types of side effects. Anthracycline chemotherapy drugs like doxorubicin (Adriamycin®) and epirubicin (Ellence®) are known to cause heart-related side effects. Previous studies have suggested that statins—drugs used to reduce cholesterol—may prevent anthracycline-related heart damage. Atrovastatin is an oral statin that is commonly used to lower blood cholesterol levels. This study will investigate whether women being treated for early-stage breast cancer who receive Adriamcyin or Ellence along with atrovastatin experience fewer heart-related side effects than women who receive Adriamycin or Ellence and a placebo. To be eligible, a woman must be scheduled to receive Adriamycin or Ellence after surgery.
This is a Phase II trial

Laser Treatment for Blood Vessels Affected by Radiation

Quality of Life Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser (NCT01803516)

Summary

Radiation treatments for breast cancer can have long-term effects on the skin. Telangiectasia–dilated blood vessels that can look like a red rash on the skin— is a common side effect. Pulsed dye laser is a heat treatment that may cause the blood vessels to become smaller and less visible. The purpose of this study is to see if receiving pulsed dye laser treatment for radiation-induced telangiectasias affects a woman’s overall well-being. To be eligible, participants must have been treated for breast cancer with surgery and radiation and developed radiation-induced telangiectasia.

Omega-3 Fatty Acids to Reduce Paclitaxel-Related Pain

A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome (NCT01821833)

Summary

Omega-3 fatty acids are nutrients that are essential for good health. Omega-3 fatty acids are not made by the body; they are obtained through foods or supplements. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat breast cancer. One of it most common side effects is pain. Studies suggest that omega-3 fatty acids may help decrease Taxol-related pain. This study is looking at whether omega-3 fatty acids are better than a placebo for reducing pain. To be eligible, participants must be scheduled to receive treatment with the chemotherapy drug paclitaxel.

Using Regional & General Anesthesia to Reduce Pain & Nausea After Surgery & Reconstruction

Pectoral Nerve Block vs. Standard Anesthesia in Patients Undergoing Mastectomy and Immediate Breast Reconstruction: Impact on Post-operative Pain and Nausea/Vomiting(NCT02913573)

Summary

To take part in this study, you must be scheduled to have a mastectomy followed by immediate breast reconstruction with a tissue expander or implant. General anesthesia is used before breast cancer surgery. A pectoral nerve block is an anesthetic used to numb the chest area. In this study, researchers will see whether women who receive a pectoral nerve block along with general anesthesia immediately before surgery have less pain, nausea and vomiting after surgery and reconstruction than women who receive general anesthesia alone.
This is a Phase II trial

Breath Holding to Protect Heart and Lungs During Left-Breast Radiotherapy

Pilot Study For Prone Breath Hold Technique to Decrease Cardiac and Pulmonary Doses in Women Receiving Left Breast Radiotherapy (NCT02379988)

Summary

Women with breast cancer in their left breast who are treated with radiation have an increased risk of developing radiation-induced heart and lung problems. Deep Inspiration Breath Hold (DIBH), a technique where a woman holds a deep breath while receiving radiation, may help minimize radiation exposure to the heart and lungs. This study is investigating the effect of DIBH in patients receiving radiation for left sided breast cancer. To be eligible, participants must be a patient of Dr. Victor J. Gonzalez at the Arizona Cancer Center at University of Arizona Health Sciences Center.
This is a Phase O trial

Self-Care Toolkit for Managing Side Effects After Surgery

Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients (NCT02387320)

Summary

Side-effects associated with breast cancer surgery can include pain, anxiety, nausea, fatigue, and sleep disturbance. Researchers have developed a self-care toolkit to help women learn about mind-body skills and tools that can help them cope with these side effects. This study will compare the effectiveness of this kit to the standard of care for helping women reduce these side effects. To be eligible, a woman must be newly diagnosed with breast cancer and be receiving treatment at the San Antonio Military Medical Center Oncology Clinic.

A Program to Reduce Insomnia (Trouble Sleeping) Caused by Cancer or its Treatment

Brief Behavioral Intervention for Insomnia During Chemotherapy (NCT02165839)

Summary

Many women report that they experience insomnia--trouble sleeping--during their breast cancer treatment. A behavioral therapy program may help breast cancer patients cope with their insomnia. This study will compare a behavioral therapy program for insomnia to a healthy eating program in women being treated with chemotherapy or a biological therapy, like Herceptin, for early-stage breast cancer. To be eligible, a woman must have insomnia that began or got worse when she was diagnosed with cancer or began systemic treatment with chemotherapy or biological therapy.
This is a Phase III trial

Preventing Nausea and Vomiting From Chemotherapy

A Pilot Study to Evaluate the Efficacy of Fosaprepitant and Granisetron Transdermal System for the Prevention of Acute and Delayed Nausea and Vomiting in Breast Cancer Patients and to Identify Predictors of Response (NCT01649258)

Summary

Nausea and vomiting are common side effects of chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Fosaprepitant dimeglumine, which is delivered via IV, and the granisetron transdermal system patch are both antiemetic drugs. Researchers believe combining the two will make them more effective. This study is investigating how well fosaprepitant dimeglumine and the granisetron transdermal system patch work to prevent nausea and vomiting in breast cancer patients undergoing chemotherapy.

Botox to Reduce Pain Caused by Expanders During Reconstruction

Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial (NCT01591746)

Summary

Breast reconstruction with implants is typically done in two stages. At the time of surgery, a temporary implant (tissue expander) is inserted, which over the course of several months is slowly filled with saline. A second surgery is then performed to replace the expander with a permanent implant. During expansion, patients often experience significant pain and discomfort. BTX-A (Botox) is currently used to reduce pain caused by migraine headaches and chronic tennis elbow as well as for post-operative pain control. This study will assess the safety and effectiveness of using Botox to reduce pain and improve physical well-being during tissue expansion. It is the first time Botox is being studied in breast cancer survivors who are having breast reconstruction with tissue expanders. To be eligible for this study, patients must be scheduled to have breast reconstruction following a skin-sparing or nipple-sparing mastectomy.
This is a Phase III trial

Other

Using MRI of the Heart to Study Effects of Radiation Therapy for Left-Sided Breast Cancer

Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy (NCT02199366)

Summary

Women who receive radiation therapy to treat breast cancer in their left breast are at risk of developing heart problems. Magnetic Resonance Imaging (MRI) scans produce detailed images of the inside of the body. This study is looking at whether MRI scans of the heart can identify changes in heart function that develop after radiation therapy. To be eligible, a patient must be scheduled to receive radiation therapy for a stage I-III left-sided breast cancer.
This is a Phase I trial

University of New Mexico Cancer Center Breast Cancer Registry and Tissue Bank

Expanded Breast Cancer Registry and Tissue Repository (NCT00322894)

Summary

The New Mexico Tumor Registry (NMTR) collects information about breast cancer incidence and survival in the state of New Mexico. The type of treatment patients receive is not routinely collected by the registry. The Expanded Breast Cancer Registry and Tissue Repository (EBCR) is a new registry that will collect this information. Patients will also have the opportunity to donate extra breast tissue samples to the tissue bank (repository). Researchers will use the tissue bank to conduct laboratory-based genetic studies on breast cancer risk, prognosis and survival. To be eligible, participants must have been diagnosed within one year and be receiving breast cancer treatment at the University of New Mexico Comprehensive Cancer Center.

Using Brain Imaging to Study the Effect of Chemotherapy on the Brain

Amyloid Plaque Deposition in Chemotherapy-Induced Cognitive Impairment (NCT02317783)

Summary

Many cancer patients have thinking and memory problems due to cancer or its treatments. The reasons for this "mental fog" referred to as chemo brain are not always known. This study seeks women diagnosed with breast cancer and treated with chemotherapy for a study aimed at better understanding chemo brain. To be eligible, women must have completed chemotherapy within the last 6 months, but not more than 36 months.
This is a Phase II trial

Evaluating an Imaging Tool to Monitor Tumor Response to Chemo Given Before Surgery

Monitoring Neoadjuvant Chemotherapy Response In Breast Cancer Patients Using Diffuse Optical Spectroscopic Imaging (DOSI) (NCT02510456)

Summary

Giving chemotherapy before surgery--called neoadjuvant treatment--allows researchers to study how the tumor is responding to the treatment. Diffuse Optical Spectroscopy Imaging (DOSI) uses a handheld device that is placed against the skin to assess tumor metabolic activity. In this study, researchers will investigate whether DOSI is an effective way to evaluate how a tumor is responding to chemotherapy given before surgery. To be eligible, a woman must be planning to receive neoadjuvant chemotherapy prior to surgery.

Therapeutic Light to Reduce Sleep Problems During Chemo for Early-Stage Breast Cancer

Bright Light on Fatigue in Women Being Treated for Breast Cancer: A Pilot Study (NCT02658708)

Summary

Trouble sleeping and fatigue are common problems among cancer patients receiving chemotherapy. Previous studies have suggested these symptoms may occur because chemotherapy disrupts a patient's circadian rhythm--the internal biological clock that regulates when a person feels sleepy. Bright light helps maintain a strong circadian rhythm in the body. This study is investigating the feasibility and effectiveness of using therapeutic bright light tailored to an individual's circadian rhythm to improve sleep and reduce fatigue in breast cancer patients receiving chemotherapy. To be eligible, a patient must have early-stage breast cancer, be having sleep problems, and be scheduled to receive 21-day cycle of intravenous chemotherapy.
This is a Phase O trial

Analyzing Genetic Mutations Before and After Treatment with Targeted Therapies

Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy (NCT01775072)

Summary

Most genetic mutations found in cancer cells are not passed down from parents (inherited), but occur when the cells make mistakes when they divide. Most cancers have many mutations. Some of these mutations help drive the tumor's growth, while others are just bystanders. In this study, researchers will analyze the genetic mutations seen in tumor tissue that has previously been collected during a surgery or biopsy and compare these mutations to those found in the patient's DNA. They will also try to identify the mutations that help predict whether the cancer will respond to a certain treatment. And they will look at how genes in the tumor change over time in response to targeted cancer therapies. To be eligible, patients must be receiving ongoing care at Memorial Sloan Kettering Cancer Center.

Study of Taxane-Related Neuropathy in Early-Stage Breast Cancer

Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer (NCT02125019)

Summary

Paclitaxel (Taxol®) and docetaxel (Taxotere®) are taxane-based chemotherapies commonly used to treat breast cancer. Peripheral neuropathy--numbness, tingling, or burning pain in the hands or feet--is a common side effect of taxane-based chemotherapy. This study will use walking and balance skill tests to evaluate peripheral neuropathy symptoms in individuals with early-stage breast cancer receiving a taxane-based chemotherapy.
This is a Phase II trial

Imaging the Patterns of Breast Cancer Early Metastases

Imaging the Patterns of Breast Cancer Early Metastases (NCT02706964)

Summary

Different types of imaging methods can be used to detect whether breast cancer has spread to other parts of the body (metastasized). CT scans and PET/CT scans are used to detect metastases in other parts of the body. Magnetic resonance imaging (MRI) can be used to detect metastases to the brain. In this study, women who are at high risk for developing metastases will have a single whole-body PET/CT scan, a CT scan and a single brain MRI scans to see if early signs of metastases can be identified.

Reducing Acid Levels Around Cancer Cells to Make Chemo Work Better

Inhibiting Fatty Acid Synthase to Improve Efficacy of Neoadjuvant Chemotherapy (NCT02595372)

Summary

Scientists have found that cancer cells can be surrounded by high acid levels. Laboratory studies suggest reducing these acid levels may make chemotherapy work better in patients with triple negative breast cancer. Omeprazole (Prolisec®) is a drug given to reduce stomach acid. Researchers think giving you Prolisic before you receive chemotherapy may make it easier for the chemotherapy to kill cancer cells. To take part in this study, you must have triple negative breast cancer. </p> Omeprazole (Prolisec®) is a type of drug called a proton pump inhibitor. It is used to reduce stomach acid levels and to treat gastroesphageal reflux disease (GERD). If you have triple-negative breast cancer—a tumor that is ER-, PR-, and HER2-negative—you typically receive chemotherapy before surgery. This is called neoadjuvant treatment. In this study, the Prolisec is given before the neoadjuvant treatment used for stage IC-III triple-negative breast cancer.
This is a Phase II trial

Testing Tumors to Personalize Cancer Therapy

Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program (NCT01772771)

Summary

Cancer cells have genes that have changed (mutated.) Scientists are developing cancer treatments that work best in tumors with specific changes (mutations). If you enroll in this study, the researchers will perform tests on a piece of your tumor to see what types of mutations it has. They will collect this information in a database on tumor mutations. This will help the researchers learn more about tumor mutations. It will also allow them to let you know when a clinical trial opens that is testing new drugs for your type of tumor. To take part, you must be able to go to the University of Texas MD Anderson Cancer Center in Houston for a scheduled visit.

Creating a Model to Study How Triple Negative Tumors Respond to Treatment

Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer (NCT02247037)

Summary

Researchers are trying to identify the best treatment for triple negative (ER-, PR-, HER2-) breast cancer. Giving chemotherapy before surgery (called neoadjuvant treatment) allows researchers to study how a tumor responds to a specific cancer therapy. Scientists are looking for new ways to develop models of triple negative tumors that they can use in the lab to study new drugs or new drug combinations. Placing tumor tissue taken from patients into mice is one way to study new treatments and treatment combinations. In this study, patients will donate tumor tissue for scientists to use to study triple-negative breast cancer. To be eligible for this study, a patient must be a candidate for neoadjuvant treatment and be undergoing surgery at a hospital that is part of the Mount Sinai Health System.

Developing a Personalized Approach to Cancer Treatment

Feasibility, Validation and Implementation of Genomic Testing for Chemotherapy and Endocrine Sensitivity of HER2 Negative Primary Invasive Breast Cancer (Clinical Stage I to III) (NCT01334021)

Summary

Scientists are trying to develop ways to determine which cancer drugs will be most effective for which patients. In this study, the researchers will collect a tumor sample from women with HER2-negative breast cancer who have not yet had chemotherapy and/or hormone therapy, perform a genetic test on the tumor sample, and then follow the women for five years to see if their cancer recurs. The goal of the study is to see if the test the researchers have developed can predict how the tumor will respond to chemotherapy or hormone therapy. Because this is an investigational test, neither the doctor nor the participant will learn the test results or be able to use the results to make treatment decisions. To be eligible, participants must have a primary tumor that is at least 1 cm in diameter.

Studying the Effect of Chemotherapy on the Brain in Older Women

A Pilot Study of Structural and Functional Brain Magnetic Resonance Imaging Findings of Chemotherapy Toxicity in Older Women With Breast Cancer (NCT01992432)

Summary

Chemotherapy can cause short-and long-term difficulties with cognitive functioning, a problem often referred to as "chemo brain." Older adults may be at increased risk of developing cognitive problems from chemotherapy. This study will use advanced MRI techniques to characterize the changes that occur in the brain of women age 65 and older receiving adjuvant chemotherapy. Results of this study will lay the foundation for future, larger scale studies on the impact of chemotherapy on cognitive functioning in adults age 65 and older.

Neuropathy & Problems with Balance Following Taxane-Based Chemo and/or Radiation

The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients (NCT02391818)

Summary

Certain types of chemotherapy can cause peripheral neuropathy--weakness, numbness or pain in the hands and feet--which can increase the risk of falls or injury. Breast cancer patents who receive a taxane-based chemotherapy, such as ACT (Adriamycin®, Cytoxan®, Taxol®), are at increased risk of developing peripheral neuropathy. This study will evaluate balance problems that occur in patients receiving ACT and/or radiation therapy.

Evaluating the Effects of Chemotherapy on Ovarian Function

Multi-Center Study of Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer and Lymphoma (NCT00823654)

Summary

Breast cancer treatments can affect the ovaries, making it difficult for a woman to later conceive a child. They can also bring on early menopause. Ovarian functioning can be assessed by evaluating the blood levels of certain hormones the ovaries produce. The purpose of this study is to see how different cancer treatments affect the ovaries, and whether there are ways to predict which women will be more likely to go into early menopause. Women planning to have treatment with chemotherapy (CMF or ACT) or hormone therapy (tamoxifen) are eligible for this study. Women without cancer who are being treated at the NY Medical College/Center for Human Reproduction are also eligible.

Immune System Response to Breast Cancer in Women Under Age 50

A Translational Study of the Interactions Between Prior Pregnancy and the Biologic Subtype of Breast Cancer in Defining the Cancer: Host Immunologic Interaction (NCT01503190)

Summary

Researchers are interested in learning more about the role the immune system plays in cancer. This study is looking specifically at the immune system in women with breast cancer who are under age 50. The researchers will look to see if differences in their immune system correspond to different types of tumors including tumors that develop during or after a pregnancy. The investigators may go on to use some of the breast cancer tissue collected in this study to create models that could be used to develop and test new drug treatments.

Studying the Effects of Cancer Treatment on the Heart

Cardiotoxicity of Cancer Therapy: Mechanisms and Predictors (NCT01173341)

Summary

Some drugs used to treat breast cancer can result in heart-related side effects. These include the class of chemotherapy drugs called anthracyclines (like doxorubicin/Adriamycin®) and the HER2-targeted therapy trastuzumab (Herceptin®). The goal of this trial is to identify factors that may help to predict which patients are most likely to experience heart-related side effects. To be eligible, participants must be planning to receive treatment with trastuzumab or an anthracycline-based chemotherapy regimen.

Johns Hopkins Breast Cancer Program Tissue Bank

Johns Hopkins Breast Cancer Program Longitudinal Repository (NCT01937039)

Summary

By studying cells in blood and breast tissue researchers hope to learn more about what causes breast cancer and how to treat it. The Breast Cancer Program at Johns Hopkins, in Baltimore, Maryland, has started a Longitudinal Repository—also known as a tissue bank. The Repository will store blood, breast tissue and urine samples donated periodically for up to 20 years by women with breast cancer or benign breast disease as well as healthy women. The Repository will provide blood, tissue, and urine samples donated by these women to breast cancer researchers. To be eligible, participants must be receiving care at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Developing a Way to Predict Risk of Paclitaxel-Induced Peripheral Neuropathy

Validation of a Polygenic Neurotoxicity Risk Score in Patients With Unusually Severe Paclitaxel-Induced Neuropathy (NCT01953159)

Summary

Peripheral neuropathy—pain, tingling, and numbness in the fingers and toes—is a common side effect of chemotherapy. Collecting clinical data, blood samples, and self reported symptoms from patients given a paclitaxel-containing chemotherapy regimen may help researchers determine ways to predict who is at risk for developing peripheral neuropathy. This study is collecting blood samples from women who have been treated with a standard paclitaxel-containing chemotherapy regimen. It will include women with or without severe neuropathy.

Study of Persistent Post-Surgical Pain in Women With Early-Stage Breast Cancer

Biobehavioral Predictors of Persistent Post-Surgical Pain in Women Undergoing Breast Cancer Treatment (NCT02266082)

Summary

About half of all women who are treated for early-stage breast cancer experience persistent pain after surgery. In this study, researchers will investigate the relationship between biological factors (inflammatory biomarkers, stomach microenvironment, and pain sensitivity) and psychological effects (depression and anxiety) and pain in women with early-stage breast cancer. The study will also see if different types of surgery are more or less likely to be connected to the development of persistent pain. To be eligible, women must be scheduled to have breast surgery at the University of Florida Health/Shands Hospital in Gainesville, Florida.

AVB-620 to Identify Tumor Tissue in Patients Having Surgery for Early-Stage Breast Cancer

A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery (NCT02391194)

Summary

Early-stage breast cancer is typically treated with surgery to remove all of the cancer. AVB-620 is a fluorescent marker designed to light up cancer tissue and make it easier for surgeons to see the tumor's borders. Giving patients AVB-620 could help surgeons remove the tumor with clean margins, reducing the need for a second surgery. This trial will identify the best dose of AVB-620 and the time needed for it to produce an optimal fluorescence signal on an imaging system. To be eligible, a patient must be scheduled to have a mastectomy or lumpectomy and a sentinel lymph node biopsy or axillary lymph node dissection.
This is a Phase I trial

Complementary and Alternative Medicine

Comparing Hypnosis and Muscle Relaxation for Improving Self-Image After a Cancer Diagnosis

A Mind-body Intervention to Improve Body and/or Self Image: a Phase II Randomized Trial (NCT02531997)

Summary

Hypnotic relaxation therapy uses hypnosis, a technique that helps individuals enter a state of calm, alert awareness, to help people make personal changes. Progressive muscle relaxation therapy is a relaxation techniques that uses tensing and relaxing of the muscles to help people become more aware of physical sensations. This study will investigate whether hypnotic relaxation therapy is more effective than progressive muscle relaxation therapy for improving body/self-image in women who have been diagnosed with breast (or gynecologic) cancer. To be eligible, a woman must report having had a change in body/self image since her cancer diagnosis, wish to improve her body/self-image, and be able to attend sessions at the University of Michigan Cancer Center.

Glutamine Supplements to Prevent Radiation-Related Side Effects

Glutamine for the Prevention of Radiation Toxicity in Subjects Undergoing Breast (NCT02012608)

Summary

Radiation used to damage cancer in your body can also damage healthy cells. Glutamine is an amino acid that helps fuel cell division. Previous studies have found that glutamine supplements may help prevent or treat skin toxicity by promoting DNA or tissue damage repair to healthy cells. This study will compare the effects of glutamine and a placebo in patients with stage I or stage II breast cancer who are having accelerated partial breast radiation following a lumpectomy (breast conserving surgery) for their breast cancer treatment.
This is a Phase II trial

Effect of Omega-3 Fatty Acids Given Before Surgery on Breast Cancer Cells

A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma (NCT01869764)

Summary

Omega-3 fatty acids are essential nutrients for good health. They are not made by the body, and are obtained only through foods or supplements. Laboratory studies suggest omega-3 fatty acids can slow the growth of cancer cells. This study is comparing the effect of omega-3 fatty acids to the effect of a placebo on breast cancer cells. To be eligible, participants must be planning to have breast cancer surgery (lumpectomy or mastectomy) at least 7 days from the start of the study.
This is a Phase II trial

Preventing Recurrence

Identifying Disseminated Tumor Cells in Bone Marrow After Breast Cancer Treatment

PENN-Surveillance Markers of Utility for Recurrence After (Neo)Adjuvant Therapy for Breast Cancer (NCT02732171)

Summary

Studies have found that women who have disseminated tumor cells (DTCs) in their bone marrow are at greater risk of having a breast cancer recurrence than women without DTCs. A bone marrow aspiration can be used to look for DTCs. In this study, women who received neoadjuvant or adjuvant chemotherapy within the past 5 years and are at increased risk for recurrence will have a bone marrow aspiration. Those who are found to have DTs in their system will have an opportunity to enroll in a separate clinical trial that is evaluating the effectiveness of using a therapy that targets DTCs to prevent recurrence.
This is a Phase O trial

Studying Disseminated Cancer Cells Before and After Chemotherapy

Effect of Neoadjuvant Chemotherapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells (NCT00353483)

Summary

Single tumor cells or small groups of tumors cells that are found in the lymph or blood are often referred to as disseminated tumor cells (DTCs). Chemotherapy that is given before surgery may not kill all cancer cells. DTCs that are not killed by chemotherapy are believed to have a unique set of tumor marker proteins. This study will compare the tumor markers seen on DTCs detected prior to chemotherapy to the tumor markers seen on any DTCs present after chemotherapy. This will help the researchers determine whether the tumor markers on DTCs can be used to predict which patients are most likely to have a breast cancer recurrence. To be eligible, participants must be planning on receiving chemotherapy before surgery.

MRI, Ultrasound & Mammography Before Surgery in Women with HR- Stage I-II Breast Cancer

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer (NCT01805076)

Summary

Mammography and ultrasound are routinely used before surgery to evaluate breast tumors. Researchers think using Magnetic Resonance Imaging (MRI) in addition to mammography and ultrasound before surgery will help doctors evaluate the tumor and make decisions regarding the best surgical treatment. This study will compare surgical results seen in women who receive mammography, ultrasound and MRI before surgery with surgical results seen in women who receive mammography and ultrasound before surgery.
This is a Phase III trial

MRI Before Breast Conserving Surgery for Newly Diagnosed Early-Stage Breast Cancer

Breast Cancer Staging MAgnetic Resonance for Treatment (B-SMART) (NCT00948285)

Summary

Breast conserving surgery removes the the tumor along with a rim of normal tissue (a surgical margin). Magnetic resonance imaging (MRI) is not currently used before surgery to help define the surgical area. This study will evaluate whether using MRI along with mammography and ultrasound is more effective than using mammography and ultrasound alone before surgery to obtain clean margins, reduce the need for a second surgery, and achieve a good cosmetic result. To be eligible, a woman must be a candidate for breast conserving surgery (lumpectomy).

Having Children

Improving Fertility Preservation

A Randomized Open Label Clinical Trial of Fixed Dose Letrozole vs. Titrated Letrozole for In Vitro Fertilization With Cryopreservation of Oocytes and Embryos in Breast Cancer Patients (NCT01035099)

Summary

Some breast cancer treatments may affect a woman's ability to become pregnant. Women can choose to undergo in vitro fertilization (IVF) prior to chemotherapy or radiation so that they can store their eggs and try to become pregnant at a later date. IVF involves ovarian stimulation and egg retrieval. Conventional ovarian stimulation often results in very high estrogen levels, which may be unsafe for breast cancer patients. Letrozole (Femara®) is an aromatase inhibitor used to treat hormone-sensitive tumors in postmenopausal women. It can reduce estrogen levels during IVF while still allowing for effective ovarian stimulation. This trial will compare the effectiveness of two different ways of administering letrozole during ovarian stimulation in patients who are scheduled to undergo IVF for fertility preservation due to breast cancer.