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Primary Breast Cancer clinical trials

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NCT ID: NCT01049425 Completed - Clinical trials for Primary Breast Cancer

Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

planB
Start date: February 5, 2009
Phase: Phase 3
Study type: Interventional

The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient, who will only have a modest benefit from this compound. Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to identify patients who should not receive chemotherapy. Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms, to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors.

NCT ID: NCT01033162 Completed - Clinical trials for Primary Breast Cancer

Effectiveness of the CHESS eHealth Cancer Support Intervention in Population-based Care

Start date: November 2009
Phase: N/A
Study type: Interventional

The study's aim is to provide information about the clinical and business cases for comprehensive interactive cancer communication systems (ICCS) in the context of real world use for cancer care. This study will be conducted within the Kaiser Permanente Northwest (KPNW) healthcare system. Outcomes for this study include amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits.

NCT ID: NCT01019616 Active, not recruiting - Clinical trials for Primary Breast Cancer

Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

Start date: March 4, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.

NCT ID: NCT00793377 Completed - Clinical trials for Primary Breast Cancer

Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-Doc) Versus Dose-Dense Doxorubicin and Docetaxel (ADoc) in Breast Cancer

Start date: n/a
Phase: Phase 3
Study type: Interventional

The primary objective of this trial is to compare the rate of pathologically complete remissions achieved using a preoperative dose-intensified 8 week therapy consisting of adriamycin and docetaxel with a preoperative sequential 24 week regimen consisting of adriamycin/cyclophosphamide followed by docetaxel, in patients with operable carcinoma of the breast. Secondary aims are to assess disease-free and overall survival, the rate of complete and partial responses by palpation and imaging methods, the rate of breast-conserving operations, and the toxicity of the two chemotherapy regimens. Women meeting the following criteria will be eligible for the study: those with operable breast cancer (T2-3 N0-2 M0), with the diagnosis histologically confirmed by biopsy, and measurable disease on mammography or sonography or breast MRI (the most appropriate method should be chosen by the investigator). After the patients have given written informed consent, they will be randomly assigned to the study treatments. Patients in group I will receive four cycles of combination chemotherapy consisting of adriamycin 50 mg/m2 (15 min i.v. infusion) and docetaxel 75 mg/m2 (1 h i.v. infusion) repeated every 14 days, followed by surgery 9-10 weeks after the start of therapy. Patients in group II will receive four cycles of adriamycin 60 mg/m2 (15 min i.v.) and cyclophosphamide 600 mg/m2 (1 h i.v.) every three weeks, followed by four cycles of docetaxel 100 mg/m2 (1 h i.v.) every three weeks. Surgery will be performed during week 25 or 26. Patients in both groups will additionally receive oral doses of tamoxifen 20 mg once daily for 5 years, starting on the first day of chemotherapy. Surgery will consist of removal of the remaining tumor (breast-conserving resection or mastectomy) and axillary dissection (Sentinel node biopsy is allowed if the patient is involved in a randomized trial. Radiotherapy is applicated according to standard proceedings of participating center. A second randomization for additional versus no additional postoperative chemotherapy is recommended in ypN+ disease. Patients with disease progression during preoperative therapy, chemotherapy can be stopped and surgery can be performed immediately.

NCT ID: NCT00527449 Completed - Clinical trials for Primary Breast Cancer

Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel

ETCat01
Start date: May 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to optimize results in neoadjuvant chemotherapy of local advanced primary breast cancer. Therefore patients become first 3 cycles of Epirubicin/Docetaxel followed by 3x Carboplatin/Docetaxel.

NCT ID: NCT00172068 Terminated - Clinical trials for Primary Breast Cancer

Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow

MRD-1
Start date: January 2002
Phase: Phase 2
Study type: Interventional

Metastatic bone disease is an important prognostic factor for survival which will in median be close to two years after first diagnosis of osseous metastases. This open-label study will investigate the safety and efficacy of zoledronic acid in patients with breast cancer and minimal residual disease in the bone marrow.