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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01019616

Enrollment

400

Registered

2009-11-25

Start date

2011-03-04

Completion date

2022-06-30

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Breast Cancer

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.

Interventions

DRUGpaclitaxel/anthracycline

standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026