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

NCT02879513 | Unknown Phase 3 DMC

• 1 other identifier: RenJiH-BC-003
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  Up to 5 years

Secondary Outcomes (5)

• overall survival (OS)

  Up to 5 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  4 months during adjuvant therapy

• regional recurrence free survival (RRFS)

  5 years

• local recurrence free survival (LRFS)

  5 years

• distant-disease- free survival (DDFS)

  5 years

Study Arms (4)

Switch to CEF

ACTIVE COMPARATOR

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.

Drug: Epirubicin; Drug: Cyclophosphamide; Drug: 5-fluoruracil

Continue the neoadjuvant regimen

EXPERIMENTAL

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.

Drug: Paclitaxel; Drug: Cisplatin

Pathological complete response group with chemotherapy

EXPERIMENTAL

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.

Drug: Paclitaxel; Drug: Cisplatin

Pathological complete response group with no chemotherapy

NO INTERVENTION

Interventions

Paclitaxel DRUG

Also known as: Taxol

Continue the neoadjuvant regimen; Pathological complete response group with chemotherapy

Cisplatin DRUG

Continue the neoadjuvant regimen; Pathological complete response group with chemotherapy

Epirubicin DRUG

Switch to CEF

Cyclophosphamide DRUG

Switch to CEF

5-fluoruracil DRUG

Also known as: 5-FU

Switch to CEF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥18years and ≤70 years;
• Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy.
• Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST).
• Endocrine therapy and trastuzumab were allowed to use.
• ECOG 0-2;
• 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;
• No obvious main organs dysfunction.

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ductal, Breast; Inflammatory Breast Neoplasms

Interventions

Paclitaxel; Cisplatin; Epirubicin; Cyclophosphamide; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Jinsong Lu, MD

CONTACT

lujjss@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Breast Surgery

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: August 25, 2016
• Study Start: January 1, 2014
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2022
• Last Updated: March 23, 2020

Record last verified: 2019-03

Locations

CN (1)