Clinical trial NCT02879513: Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy
Official title: A Randomized Phase III Trial of Comparing Combination Administration of Paclitaxel and Cisplatin Versus CEF as Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Invasive Ductal Breast Cancer
Tubular Breast Cancer
Mucinous Breast Cancer
Inflammatory Breast Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 290
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.

Detailed description: All the patients who had neoadjuvant chemotherapy and had pathological complete response (pCR) or partial response to DP will enrolled in this trial. Those who had pCR will randmized to have two cycles of DP as adjuvant chemotherapy or have no further chemotherapy. Those patients who had PR will be randomized to have two cycles of DP or four cycles of CEF. All the patients with hormonal receptor positive or Her2 overexpress tumors are allowed to accept endocrine therapy or anti-Her2 target therapy.

Eligibility criteria: Inclusion Criteria:

1. Women aged ≥18years and ≤70 years;
2. Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy.
3. Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST).
4. Endocrine therapy and trastuzumab were allowed to use.
5. ECOG 0-2;
6. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL;
7. No obvious main organs dysfunction.

Exclusion Criteria:

1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
2. Patient is pregnant or breast feeding;
3. Metastatic breast cancer;
4. Any evidence of sense or motor nerve disorders;
5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;
6. Any concurrent malignancy other than breast cancer;
7. Know severe hypersensitivity to any drugs in this study.

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: overall survival (OS)
timeFrame: Up to 5 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 4 months during adjuvant therapy
measure: regional recurrence free survival (RRFS)
timeFrame: 5 years
measure: local recurrence free survival (LRFS)
timeFrame: 5 years
measure: distant-disease- free survival (DDFS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine, Renji Hospital
state: Shanghai
Study officials:
References: