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An Open Randomised Trial of Zoladex versus CMF as Adjuvant Therapy in the Management of Node Positive Stage II Breast Cancer in Pre/Peri-Menopausal Women Aged 50 Years or Less

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15682734
Enrollment
Unknown
Registered
2002-08-19
Start date
1995-01-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Breast Cancer Breast

Interventions

Patients are randomised to one of two treatment arms: 1. Arm A: Zoladex, 3.6 mg given subcutaneously every 28 days for 2 years or until a treatment endpoint is reached. 2. Arm B: Chemotherapy with c

Sponsors

AstraZeneca Clinical Research Group (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pre- or peri-menopausal 2. Node positive stage II breast cancer, at entry to study, consisting of: 2.1. Histologically proven operable invasive breast cancer 2.2. Pathologically involved lymph nodes c. No evidence of metastatic disease 3. No previous systemic therapy for breast cancer 4. Adequate hepatic, renal and haematological function 5. No bilateral oophorectomy or radiotherapy to the ovaries 6. No concurrent or previous malignancy, except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration—

Secondary

MeasureTime frame
Not provided at time of registration—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026