NCT00544765

Docetaxel, Doxorubicin and Cyclophosphamide Versus Vinorelbine and Capecitabine in Patients Not Sufficiently / Sufficiently Responding as Preoperative Treatment of Locally Advanced or Operable Primary Breast Cancer

A Multi-center Randomized Phase III Study Evaluating 4 Cycles of Docetaxel, Doxorubicin and Cyclophosphamide Versus 4 Cycles of Vinorelbine and Capecitabine in Patients Not Sufficiently Responding to 2 Cycles of TAC and 4 Cycles of TAC Versus 6 Cycles of TAC in Patients Sufficiently Responding to 2 Cycles of TAC as Preoperative Treatment of Locally Advanced or Operable Primary Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,014 (actual)
• Sponsor: GBG Forschungs GmbH · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary objective of the study in patients without a sufficient sonographic response (i.e. iNC) to 2 cycles of TAC as preoperative treatment of operable (T\>/= 2cm, N0-2,M0) primary breast cancer: To determine the response rate determined by sonography (iRR = iCR+iPR) of further 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of vinorelbine and capecitabine (NX) (TAC vs. NX) Primary objective of the study in patients with a sufficient sonographic response (i.e. iRR = iPR or iCR) to the first 2 cycles of TAC as preoperative treatment of operable (T\>/=2cm, N0-2,M0) primary breast cancer: To determine the pCR rate of 6 cycles vs. 8 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC x 6 vs. TAC x 8)

Detailed description

Prospective, randomized phase III trial Study population I: operable (T\>/=2cm, N0-2,M0) primary breast cancer Study population II: locally advanced (T4 a-d, N0-3,M0) primary breast cancer patients All patients will receive 2 cycles of TAC. Thereafter * Patients sufficiently responding (iPR, iCR) will be randomized to either 4 further cycles of TAC or 6 further cycles of TAC * Patients non-sufficiently responding (iNC) will be randomized to either 4 further cycles of TAC or 4 cycles of NX: TAC: Docetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks NX: Vinorelbine 25 mg/m² as a 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks If a patient shows progressive disease during the first 2 cycles of TAC she will not be randomized and will be treated according to the discretion of the investigator. In patients with disease progression during further preoperative therapy, the treatment should be discontinued and patients should be treated by immediate surgery. In case of inoperability even after termination of chemotherapy further treatment is to the discretion of the investigator (e.g. radiotherapy). Dose reduction and/or treatment delay and treatment discontinuation are planned in case of severe hematological and/or non-hematological toxicities. After completion of chemotherapy and assessment of response, all patients should undergo surgery. Surgery should be performed 1-14 days after completion (i.e. day 21) of the last chemotherapy cycle. If the tumor is still too large for breast conservation, modified radical mastectomy is recommended. The patient can be offered autologous or heterologous reconstructive surgery. Sentinel node biopsy is allowed to be the only dissected axillary lymph node in patients with a pathological complete response and non involved sentinel node. Surgical reports will be collected and analyzed centrally. The excised breast tissue should be examined by the pathologist according to guidelines given in the appendix. Histology reports will be collected and analyzed centrally. Radiotherapy should be applied according to guidelines. Further postoperative systemic treatment is not planned except tamoxifen 20 mg p.o. daily for 5 years (starting after surgery) to patients with positive estrogen and/or progesterone receptors unless there is a contraindication for the use of tamoxifen therapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	TAC	Docetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks
DRUG	NX	Vinorelbine 25 mg/m² as a \< 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks

Timeline

• Start date: 2002-09-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-10-16
• Last updated: 2021-02-04