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

Primary Purpose

Primary Breast Cancer

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
paclitaxel/anthracycline
Sponsored by
Tao OUYANG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chemotherapy

Control

Arm Description

Outcomes

Primary Outcome Measures

distant disease-free survival (DDFS)

Secondary Outcome Measures

Full Information

First Posted
November 24, 2009
Last Updated
November 26, 2021
Sponsor
Tao OUYANG
Collaborators
Beijing Municipal Science & Technology Commission, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking University First Hospital, Peking University People's Hospital, Beijing Chao Yang Hospital, 307 Hospital of PLA
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1. Study Identification

Unique Protocol Identification Number
NCT01019616
Brief Title
Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
Official Title
A Phase Ⅲ Study of Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2011 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tao OUYANG
Collaborators
Beijing Municipal Science & Technology Commission, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking University First Hospital, Peking University People's Hospital, Beijing Chao Yang Hospital, 307 Hospital of PLA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
paclitaxel/anthracycline
Other Intervention Name(s)
Alternative Non-cross-resistant Adjuvant Chemotherapy
Intervention Description
standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel)
Primary Outcome Measure Information:
Title
distant disease-free survival (DDFS)
Time Frame
3 years after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Absolute neutrophil count (ANC) ≥1500/mm3 Platelets ≥100,000/ mm3 Hemoglobin ≥10 g/dL Adequate hepatic and renal function with: Serum bilirubin ≤1.5×UNL Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis) BUN between 1.7 and 8.3 mmol/L 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Ouyang, Doctor
Organizational Affiliation
Beijing Cancer Hospital Breast Center
Official's Role
Study Chair
Facility Information:
Facility Name
307 Hospital of Pla
City
Beijing
Country
China
Facility Name
Beijing Cancer Hospital Breast Center
City
Beijing
Country
China
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
Country
China
Facility Name
Cancer Institution and Hospital.Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
Peking University People'S Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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