Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

A Phase Ⅲ Study of Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Breast Cancer
• Intervention / Treatment: Drug: paclitaxel/anthracycline

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Peking Union Medical College Hospital
  • Beijing, China
    • Peking University People's Hospital
  • Beijing, China
    • 307 Hospital of PLA
  • Beijing, China
    • Beijing Chao-Yang Hospital
  • Beijing, China
    • Beijing Cancer Hospital Breast Center
  • Beijing, China
    • Cancer Institution and Hospital.Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients, age ≦65 years
• Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer
• Must have completed a 4-cycle neo-adjuvant chemotherapy with a standard regimen(containing anthracycline or paclitaxel)
• Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
• Postoperative residual positive lymph nodes or G1/G2/G3 of Miller & Payne Grading System
• Adequate recovery from recent surgery
• No history of other malignancies
• No currently uncontrolled diseased or active infection
• Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
• Adequate cardiovascular function reserve with a myocardial infarction within the past six month

• Adequate hematologic function with:

  1. Absolute neutrophil count (ANC) ≥1500/mm3
  2. Platelets ≥100,000/ mm3
  3. Hemoglobin ≥10 g/dL

• Adequate hepatic and renal function with:

  1. Serum bilirubin ≤1.5×UNL
  2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis)
  3. BUN between 1.7 and 8.3 mmol/L
  4. Cr between 40 and 110 umol/L
• Knowledge of the investigational nature of the study and Ability to give informed consent
• Ability and willingness to comply with study procedures.

Exclusion Criteria:

• Known or suspected distant metastases
• Concurrent malignancy or history of other malignancy
• Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
• Geographical, social, or psychological problems that would compromise study compliance
• Known or suspected hypersensitivity to anthracycline or paclitaxel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Chemotherapy	Drug: paclitaxel/anthracycline; standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel); Other Names: Alternative Non-cross-resistant Adjuvant Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
distant disease-free survival (DDFS)	3 years after surgery

Collaborators and Investigators

• Sponsor: Tao OUYANG
• Collaborators: Peking University First Hospital; 307 Hospital of PLA; Peking University People's Hospital; Peking Union Medical College Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing Chao Yang Hospital; Beijing Municipal Science & Technology Commission
• Investigators: Study Chair: Tao Ouyang, Doctor, Beijing Cancer Hospital Breast Center

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2011
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: November 24, 2009
• First Submitted That Met QC Criteria: November 24, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: D09050703570904