A Trial of Metformin in Early Breast Cancer

• Conditions: Early Breast Cancer; MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005230-18-GB
• Lead Sponsor: CIC Clinical Trials Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-09
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 3582

Inclusion Criteria

1. Subjects must have histologically confirmed invasive breast cancer and be enrolled in the trial within 12 months after the first histologic diagnosis of invasive breast cancer. 2. All subjects (both adjuvant and neo-adjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection. 3.Definitive surgery and/or chemotherapy must have been completed at least 4 weeks prior to randomization. 4. Adjuvant subjects with the following pT pN combinations are eligible: • pT1c, pN0 AND at least one of the following tumour characteristics: histologic grade 3, lymphovascular invasion, negative estrogen and progesterone receptors, HER2 positive, Oncotype Dx recurrence score > 25 (or if Oncotype Dx recurrence score is not available, Ki67 > 14%)OR • Subjects with pT2-3, pN0 OR • Subjects with pT1-3, pN1-3. The eligibility of neo-adjuvant subjects is assessed on the basis of cTNM. The same eligible TNM combinations apply. 5. Estrogen and progesterone receptor status must be known. 6. HER2 status must be known. 7. Patients must have had a bilateral mammogram within 12 months prior to randomization, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. 8. The following scans must have been performed between the first diagnosis and the time of randomization: • Chest X-Ray (or Chest CT) is mandatory • Bone scans (with x-rays of abnormal areas) if symptoms of metastatic disease • Abdominal imaging is required if liver function tests are abnormal or if there are symptoms of metastatic disease 9. Adequate haematology (exact definition in protocol) 10. Adequate biochemistry (exact definition in protocol) 11. ECOG Performance Status of 0,1 or 2 12. Age > 18 and < 75 13. Subjects must be accessible for treatment and follow-up. 14. Patients must have provided written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Subjects with a history of other malignancies (exact definition in protocol). 2. Subjects with locally recurrent or metastatic breast carcinoma. 3. Subjects whose axillary node status is unknown. 4. Known diabetes (type 1 or 2) or baseline fasting glucose > 7.0 mmol/L (126 mg/dL). 5. Known hypersensitivity or intolerance of metformin. 6. Any condition associated with increased risk of metformin-associated lactic acidosis (exact definition in protocol). 7. Currently taking metformin, sulfonylureas, thiazolidenediones or insulin for any reason. 8. Current or planned pregnancy or lactation in women of child-bearing potential (confirmed by negative pregnancy test within 7 days of randomization). Men should not father a child. Birth control requirements are defined in the protocol. 9. Concurrent or planned participation in randomized trials of weight loss, exercise or trials targeting insulin and its pathways.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified