Know Cancer

or
forgot password

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


Phase 3
18 Years
65 Years
Open (Enrolling)
Female
Primary Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

distant disease-free survival (DDFS)

Outcome Time Frame:

3 years after surgery

Safety Issue:

No

Principal Investigator

Tao Ouyang, Doctor

Investigator Role:

Study Chair

Investigator Affiliation:

Beijing Cancer Hospital Breast Center

Authority:

China: Food and Drug Administration

Study ID:

D09050703570904

NCT ID:

NCT01019616

Start Date:

December 2010

Completion Date:

December 2014

Related Keywords:

  • Primary Breast Cancer
  • Breast Neoplasms

Name

Location