A Phase 3 interventional study of TAC and NX in Breast Cancer, sponsored by German Breast Group. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by German Breast Group · Phase 3, Interventional, and Treatment
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)
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
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 2,014 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →German Breast Group is the lead sponsor of 33 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Tumor lesion in the breast with a palpable size of > 2 cm in maximum diameter. The leasion has to be measurable in two-dimensions by sonography. In case of inflammatory disease the extent of inflammation can be used as measurable lesion. The following tumor stages are eligible:
Laboratory requirements (within 14 days prior to registration):
Hematology:
Hepatic function:
Renal function:
Exclusion Criteria:
Other serious illness or medical condition:
Patients sufficiently responding (iPR, iCR) will recieve 4 further cycles of TAC
Drug: TAC
Patients sufficiently responding (iPR, iCR) will recieve 6 further cycles of TAC
Drug: TAC
Patients non-sufficiently responding (iNC) will recieve 4 further cycles of TAC
Drug: TAC
Patients non-sufficiently responding (iNC) will recieve 4 further cycles of NX
Drug: NX
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
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
Determination of pCR rates
To determine the iRR rate of 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of vinorelbine and capecitabine (NX) (TAC-NX) as a salvage treatment
Time frame: 2010
To determine the toxicity and compliance to each arm
Any grade III/IV toxicity (NCI-CTC Version 2.0) Premature treatment discontinuation
Time frame: 2010
To determine the breast conservation rate in each arm
Any breast conservation without reconstruction
Time frame: 2010
To determine the disease-free and overall survival in each arm
Any disease related event (recurrence, metastasis) and/or death after primary diagnosis
Time frame: 2010
To determine the specificity and sensitivity of a presurgical core biopsy to predict the degree of pathologic tumor regression
No microscopic evidence of residual viable tumor cells (invasive or non-invasive) in all resected specimens of the breast
Time frame: 2010
No study locations are listed for this record.
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German Breast Group