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

Primary Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01019616
• Other study ID #: D09050703570904
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 4, 2011
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2021
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Primary Breast Cancer

Intervention

Drug:
• paclitaxel/anthracycline
standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel)

Locations

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

Sponsors (8)

Lead Sponsor	Collaborator
Tao OUYANG	307 Hospital of PLA, Beijing Chao Yang Hospital, Beijing Municipal Science & Technology Commission, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Peking University First Hospital, Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	distant disease-free survival (DDFS)		3 years after surgery