Deciphering the Breast Cancer Exercise Paradox: The Role of DNA Repair and Inflammation
This randomized pilot trial studies how well an exercise intervention works in preventing breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to respond to inflammation more proficiently, helping to prevent primary and recurrent breast cancer.
NCT02235051 — Stage IIIA Breast Cancer
Status: Completed
http://inclinicaltrials.com/stage-iiia-breast-cancer/NCT02235051/
A Phase 2 Study of ABT-888 and Temozolomide for Metastatic Breast Cancer and an Expansion Cohort in BRCA1/2 Mutation Carriers
The purpose of this research study is to find out if the combination of ABT-888 and temozolomide is safe and effective in treating patients with metastatic breast cancer. ABT-888 works by obstructing a DNA enzyme called poly (ADP-ribose) polymerase (PARP) which helps repair cancer cells damaged by chemotherapy. By blocking the PARP enzyme, the cancer cells are unable to repair themselves and as a result die. The other drug in this study is temozolomide. Temozolomide is designed to damage DNA in order to prevent cancer cells from reproducing. Because PARP inhibitors, such as ABT-888, prevent cancer cells from repairing their own DNA, they enhance the potential of chemotherapy therapy like temozolomide to induce cell death. The combination of ABT-888 and temozolomide has been used in a clinical trial for treatment of other cancers and information for this research study suggests that the combination may help to inhibit growth in breast cancer. ONLY THE EXPANSION COHORT BELOW IS RECRUITING: BRCA CARRIER EXPANSION COHORT: The purpose of the expansion cohort is to further evaluate the activity and safety of this combination in BRCA mutation carriers with metastatic breast cancer.
NCT01009788 — Breast Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT01009788/
Predicting Adverse Cardiac Events in Breast Cancer Therapy (PACE in Breast Cancer)
RATIONALE: Studying samples of blood and tissue in the laboratory from women receiving doxorubicin and trastuzumab for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers for increased risk of cardiac effects. PURPOSE: This clinical trial is studying side effects involving the heart in women with breast cancer receiving doxorubicin and trastuzumab.
NCT00875238 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00875238/
A Pilot Study to Evaluate Angiogenesis After Treatment With Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) in Previously Untreated Patients With Inflammatory Breast Cancer or Locally Advanced Breast Cancer
This study will evaluate the effectiveness of the drug bevacizumab, in combination with doxorubicin and docetaxel, in improving survival of patients with inflammatory breast cancer or locally advanced breast cancer. Inflammatory breast cancer is an aggressive form of locally advanced breast cancer that often causes a red, swollen, tender breast and is associated with a poor prognosis. Bevacizumab blocks the growth of new blood vessels that supply oxygen and nutrients to tumors, and therefore, may kill cancer cells or stop their growth. Doxorubicin and docetaxel are approved drugs for treating breast cancer. Patients 18 years of age or older with stage inflammatory breast cancer who have not been treated with chemotherapy or radiation therapy may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, chest x-ray, electrocardiogram, and MUGA scan or echocardiography (see below). A mammogram of both breasts, dynamic MRI imaging of the affected breast, computed tomography (CT) of the head, chest, abdomen and pelvis, and a bone scan are done to determine the extent of disease. Participants undergo the following procedures at various intervals before, during and/or after completing chemotherapy: Tumor and skin biopsies to study the effects of bevacizumab on tumor blood vessels, tumor growth, and the biology of inflammatory breast cancer. A small piece of tumor tissue and a small piece of skin from the affected breast are removed under local anesthesia for microscopic study. Dynamic MRI to examine changes in the blood vessels and breast cancer following bevacizumab treatment. This test involves injecting a contrast liquid into a vein before scanning. A standard MRI scan is done before the dynamic MRI. Blood tests are done to 1) study clot formation and breakdown, 2) measure levels of VEGF (a substance produced by breast cancer cells) and VCAM-1 (a substance produced by cells lining blood vessel walls), and 3) check blood counts and liver and kidney function. MUGA (a nuclear medicine scan that checks the heart's pumping ability) or echocardiogram (ultrasound scan of the heart to evaluate heart function. Blood pressure monitoring Urine tests CT scans and x-rays to evaluate disease before and after treatment. Patients will have a central venous line (plastic tube) placed into a major vein in the chest before beginning treatment. The line stays in the body during the entire treatment period and is used to give chemotherapy and other medications, if needed, and to draw blood samples. All treatment is given on a single day every 3 weeks. This constitutes one treatment cycle. Cycle 1 consists of bevacizumab alone; cycles 2 through 7 consist of bevacizumab with doxorubicin and docetaxel. During each cycle, patients also receive injections under the skin of G-CSF, a drug that raises the number of infection-fighting white blood cells, which are often decreased as a side effect of chemotherapy. After cycle 7, patients may require surgery and radiation or radiation alone. After radiation treatment, bevacizumab is re-started, given alone every 3 weeks for an additional eight cycles. Patients whose tumors are positive for estrogen or progesterone receptors will be advised to take the drug tamoxifen or anastrozole for 5 years to decrease the chances of disease recurrence. This would begin with cycle 8.
NCT00016549 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00016549/
Patterns of Breast Cancer Management and Prognosis of Breast Cancer in Chinaļ¼a Multicenter, Prospective, Real-world Cohort Study
This is a multicenter, prospective, e, real-world cohort survey initiated by researchers to focus on the patterns of breast cancer management and prognosis of breast cancer in China, and to establish the multicenter, prospective breast cancer data platform. A total of 18 sites in Guangdong and Henan have cooperated to build a cooperative network unit. The sites will conduct prospective and standardized records concerning the clinical pathological features, treatment and prognosis of the early breast cancer patients who are treated in their own site each year, registering in the REDCap system.This real-world cohort study aims to provide a representative and reliable survey data of epidemiological characteristics, clinical treatment and prognosis of patients with early breast cancer in China and explore the establishment of a national multi-center breast cancer data platform model.
NCT04076111 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT04076111/
QUANTIFICATION OF CIRCULATING ENDOTHELIAL CELLS (CEC) AND PLASMA ANGIOGENIC FACTORS IN PATIENTS WITH BREAST CANCER
RATIONALE: Studying samples of blood in the laboratory from patients with current or previous cancer may help doctors learn more about biomarkers related to cancer. PURPOSE: This research study is looking at blood samples in women with breast cancer or a history of breast cancer.
NCT00898703 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00898703/
Breast Cancer Plasma Adjuvant Intra-operative Treatment (Breast Cancer PAINT)
The goal of this clinical trial is to test the safety of the use of non-thermal plasma (NTP, an ionized gas) on the tumor bed after the removal of the tumor in breast cancer patients. The main questions it aims to answer are: - To determine the safe and tolerable dose of NTP in patients with breast cancer; - To assess the safety and tolerability of NTP; - To assess the cosmetic effects of NTP treatment in patients with breast cancer. Participants will receive one treatment of the tumor bed after the removal of their breast tumor.
NCT06222788 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06222788/
Diffusion-Weighted MRI for Screening Contralateral Breast Cancers in Patients With Newly Diagnosed Breast Cancer
In women with newly diagnosed breast cancer, synchronous contralateral breast cancer is reported in 1% to 3%. During the initial diagnosis of breast cancer, it is important to detect the contralateral cancer to avoid second round of cancer therapy. Because breast MRI is a highly sensitive modality, it is used for screening of occult contralateral disease in women newly diagnosed with breast cancer and detects contralateral cancers not seen on clinical or conventional imaging (mammography and ultrasonography) in 4.1% of women. However, the use of breast MRI for screening contralateral breast cancer, is limited not only by high costs and long examination time but also by high false-positive findings resulting in more benign biopsies and extensive surgeries. In addition, the use of intravenous gadolinium-based contrast agent is contraindicated in pregnancy and in women with renal impairment or contrast material allergy contrast. Thus, there is a need to develop a more safe and cost-effective supplemental imaging modality for screening breast cancer. Diffusion-weighted (DW) MRI is a fast, functional modality that measures the movement of water molecules to create tissue contrast without the need for contrast injection. Breast malignancies exhibit hindered diffusion and appear hyperintense on DW MRI with low apparent diffusion coefficient (ADC) compared to normal surrounding tissue. A number of studies have shown that the use of DW MRI can significantly reduce the false positives and unnecessary benign biopsy of breast MRI. Several studies have explored how to use DW MRI as a stand-alone tool for breast cancer screening, and recent results have shown that DW MRI is more useful than conventional imaging in detecting small breast cancer. However, most of these studies were retrospective with inconsistent results. Thus, a prospective multicenter study with standardized acquisition and interpretation protocols in a large population is needed to determine the efficacy of DW MRI for breast cancer screening. The purpose of our study is to determine whether DWI improves the performance of preoperative DCE MRI in detecting clinically occult contralateral breast cancers.
NCT05307757 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05307757/
Effectiveness of Olaparib Plus Trastuzumab in HER2-positive BRCA-mutated Advanced Breast Cancer Patients (The OPHELIA Study)
This is a multicenter, open-label, single-arm, phase II clinical trial, phase II trial will evaluate the efficacy and safety of olaparib plus trastuzumab in patients with HER2[+], BRCA-mutated advanced breast cancer
NCT03931551 — Advanced Breast Cancer
Status: Terminated
http://inclinicaltrials.com/advanced-breast-cancer/NCT03931551/
A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage I-IV Breast Cancer
Despite advances in surgical, radiation and medical therapies of early stage breast cancer, some patients will experience disease recurrence. Because recurrence may not happen for years after definitive treatment, there is a period of time between resection and relapse when micrometastatic disease may be amenable to immune eradication or modulation. While the ultimate goal of any cancer treatment is clinical efficacy, the immediate urgency in breast immunotherapy is to define treatments that have immunologic efficacy. In this study, the investigators will determine whether a vaccine consisting of nine-class I breast specific peptides plus a class II tetanus toxoid helper peptide is immunogenic when administered with poly-ICLC to participants with stage IB to IIIA breast cancer in the adjuvant setting.
NCT01532960 — Breast Cancer
Status: Terminated
http://inclinicaltrials.com/breast-cancer/NCT01532960/