Clinical trial · Interventional
Neoadjuvant Treatment of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Triple-Negative or Her2 Positive Breast Cancer
A Multi-Center, Randomized Study of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Neoadjuvant Treatment of Triple-Negative or Her2 Positive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): TAC treatment was associated with better survial outcome compared with TC treatment, we terminated recruiting and waiting for longer follow up period.
Summary
Brief summary (as posted)
The purpose of this study is to compare the pathological complete response (pCR) rate in triple-negative or Her2 positive breast cancer patients treated with neoadjuvant docetaxel, anthracycline and cyclophosphamide (TAC) or docetaxel and cyclophosphamide (TC) regimen.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide | Drug | — | UNRESOLVED |
| Docetaxel, cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAC Arm
- description
- six cycles of neoadjuvant Docetaxel, Anthracycline and Cyclophosphamide
- interventionNames
- Drug: Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide
- type
- EXPERIMENTAL
- label
- TC Arm
- description
- six cycles of neoadjuvant Docetaxel and Cyclophosphamide
- interventionNames
- Drug: Docetaxel, cyclophosphamide
Primary outcomes (1)
- measure
- pathological complete remission (pCR) rate
- timeFrame
- after 6 cycles of neoadjuvant therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged ≥ 18 years and \< 70 years * Karnofsky performance status (KPS) ≥ 70 * At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer), T2N1 or locally advanced breast cancer (T3-4N0-3 or T0-4N2-3) * Biopsy specimens are available for ER, PgR and Her2 detection, patients should be with triple negative or Her2 positive breast cancer, Her2 positivity is defined as FISH/CISH Her2 positive or IHC Her2 3+, Triple-negative disease defined as negativity for ER, PgR and Her2 * Adequate bone marrow function: Neutrophil ≥ 1.5\*109/L; Hb ≥ 100g/L; PLT ≥ 100\*109/L * An estimated life expectancy of at least 12 months * Willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up * Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study * Written informed consent according to the GCP Exclusion Criteria: * Prior systemic or loco-regional treatment of breast cancer, including chemotherapy * Metastatic breast cancer * With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma * Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease * inadequate liver function (bilirubin \> 1.0 times upper normal limit \[UNL\] and ALT and/or AST\> 1.5 UNL associated with alkaline phosphatase \> 2.5 UNL; inadequate renal function (creatinine \> 1.0 times UNL and in case of limit value, Creatinine clearance \< 60 ml/min) * Contraindication for using dexamethasone * History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg) * Has peripheral neuropathy ≥ grade 1 * Patient is pregnant or breast feeding * Known severe hypersensitivity to any drugs in this study * Treatment with any investigational drugs within 30 days before the beginning of study treatment
References
Publications (4)
- BACKGROUNDYang L, Li LD, Chen YD, Parkin DM. [Time trends, estimates and projects for breast cancer incidence and mortality in China]. Zhonghua Zhong Liu Za Zhi. 2006 Jun;28(6):438-40. Chinese. PMID 17152490
- BACKGROUNDJones SE, Savin MA, Holmes FA, O'Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, Sandbach J, Hyman WJ, Khandelwal P, Negron AG, Richards DA, Anthony SP, Mennel RG, Boehm KA, Meyer WG, Asmar L. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006 Dec 1;24(34):5381-7. doi: 10.1200/JCO.2006.06.5391. PMID 17135639
- BACKGROUNDMartin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. doi: 10.1056/NEJMoa043681. PMID 15930421
- BACKGROUNDRouzier R, Perou CM, Symmans WF, Ibrahim N, Cristofanilli M, Anderson K, Hess KR, Stec J, Ayers M, Wagner P, Morandi P, Fan C, Rabiul I, Ross JS, Hortobagyi GN, Pusztai L. Breast cancer molecular subtypes respond differently to preoperative chemotherapy. Clin Cancer Res. 2005 Aug 15;11(16):5678-85. doi: 10.1158/1078-0432.CCR-04-2421. PMID 16115903