Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy

NCT ID: NCT02879513

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2022-12-31

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.

Conditions

Invasive Ductal Breast Cancer; Tubular Breast Cancer; Mucinous Breast Cancer; Inflammatory Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Switch to CEF

Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks.

Group Type: ACTIVE_COMPARATOR

Epirubicin

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

5-fluoruracil

Intervention Type: DRUG

Continue the neoadjuvant regimen

Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Pathological complete response group with chemotherapy

Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Pathological complete response group with no chemotherapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Paclitaxel

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Epirubicin

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

5-fluoruracil

Intervention Type: DRUG

Other Intervention Names

Taxol; 5-FU

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jinsong Lu

Director of Department of Breast Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinsong Lu, MD

Role: CONTACT

lujjss@163.com

Facility Contacts

Jinsong Lu, MD

Role: primary

lujjss@163.com

Other Identifiers

RenJiH-BC-003

Identifier Type: -

Identifier Source: org_study_id