Clinical trial · Interventional

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

NCT00309569CI-TRIAL-00047672completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Early Stage Breast Cancer	Early Stage Breast Carcinoma	ALIAS	0.90

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Epirubicin	Drug	Epirubicin	ALIAS
Fluorouracil	Drug	Fluorouracil	ALIAS
Methotrexate	Drug	Methotrexate	ALIAS
Surgery	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
A (pre- + postoperative chemotherapy)
description
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
interventionNames
1. Drug: Cyclophosphamide
2. Drug: Methotrexate
3. Drug: Fluorouracil
4. Drug: Epirubicin
5. Other: Surgery
type
EXPERIMENTAL
label
B (conventional postoperative chemotherapy)
description
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
interventionNames
1. Drug: Cyclophosphamide

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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)

References

Publications (0)

Data not yet available

No reference posted for this study.