Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients

A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00309569

Enrollment

429

Registered

2006-04-03

Start date

1991-10-31

Completion date

2000-09-30

Last updated

2020-10-14

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

Conditions

Early Stage Breast Cancer

Keywords

Cyclophosphamide, Methotrexate, Fluorouracil, Epirubicine, Breast Cancer

Brief summary

Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.

Interventions

DRUGCyclophosphamide

Cyclophosphamide 600mg/m2

DRUGMethotrexate

Methotrexate 40mg/m2

DRUGFluorouracil

Fluorouracil 600mg/m2

DRUGEpirubicin

Epirubucin 60mg/m2 (only node-positive patients)

OTHERSurgery

Surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients with bioptically verified breast cancer * Estrogen receptor-negative status * Age: \< 70 years * WHO Performance Status \< 2 * Laboratory parameters 1. hematopoiesis: \> 3500/mm3 leukocytes, \> 100,000/mm3 thrombocytes 2. renal function: creatinin \< 1.5mg% 3. hepatic function: GOT max. 2.5 x UNL 4. bilirubin: \< 2.0 mg % 5. metabolic parameters: Na, Ca, K in normal range * \</= 4 weeks interval since surgery * Informed consent

Exclusion criteria

* Patients with locally inoperable cancer, M1 * Other preoperative tumor-specific radiotherapy, chemotherapy or endocrine treatment * Pregnancy or lactation * General contraindication against cytostatic treatment * T4 cancer; inflammatory disease, simultaneous or sequential bilateral breast cancer * Lacking compliance or understanding of disease * Serious concomitant disease * Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)

Design outcomes

Primary

Measure	Time frame
Overall survival	—
Recurrence-free survival	—

Secondary

Measure	Time frame
Rate of breast-conserving procedures	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026