The Trial Comparing Dose-dense AC-T With PC as Adjuvant Therapy for TNBC

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this trial is to compare the 3 years DFS of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy for triple-negative breast cancer.

The other purpose of this trial is to observe the patient's tolerance.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cyclophosphamide; Epirubicin; Paclitaxel

Criteria

Inclusion Criteria:

1. Patient must accept the modified radical mastectomy

2. Patients with histologically confirmed ER(-) PR(-) and HER-2(-)

3. Positive axillary lymph nodes;negative axillary lymph node with age< 35 years or Ⅲ grade or intravascular cancer embolus.

4. Age between 18 years to 65 years

5. Able to give informed consent

6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.

7. Not pregnant, and on appropriate birth control if of child-bearing potential.

8. Adequate bone marrow reserve with ANC > 1000 and platelets > 100,000.

9. Adequate renal function with serum creatinine < 2.0.

10. Adequate hepatic reserve with serum bilirubin < 2.0, AST/ALT < 2X the upper limit of normal, and alkaline phosphatase < 5X the upper limit of normal. Serum bilirubin > 2.0 is acceptable in the setting of known Gilbert's syndrome.

11. No active major medical or psychosocial problems that could be complicated by study participation.

Exclusion Criteria:

1. received neo-adjuvant therapy

2. Cardiac dysfunction documented by an ejection fraction less than the lower limit of the facility normal by multi-gated acquisition (MUGA) scan, or 45% by echocardiogram. -The rate of Disease recurrence

3. Uncontrolled medical problems.

4. Evidence of active acute or chronic infection.

5. Pregnant or breast feeding.

6. Hepatic, renal, or bone marrow dysfunction as detailed above.