Sequential evaluation of tumours undergoing pre-operative therapy with aromatase inhibitors and metformin (setup-aim) a neo-adjuvant pilot study in operable hormone sensitive breast cancer in post menopausal wome

Not Applicable

Recruiting

• Conditions: hormone positive operable breast cancer; Cancer - Breast

• Registration Number: ACTRN12612000416897
• Lead Sponsor: Dr Vinod Ganju

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Stage 1 or 2 operable invasive breast cancer. Estrogen receptor positive (>10% cells)
Post-menopausal female
Histologically proven invasive adenocarcinoma of the breast through either a core needle biopsy or incisional biopsy Excisional biopsy will not be allowed.Tumour must be confined to either the breast or to the breast and ipsilateral axilla. A complete metastatic staging work-up will be performed prior to definitive surgery, as clinically indicated.
Age > =18 years.
Karnofsky Performance status index > =80%.
Laboratory requirements: (within 28 days prior to registration)

Haematology:
Neutrophils > =1.5 x 109/L
Platelets >=100 x 109/L
Haemoglobin > =10 g/dL
Hepatic function:
Total bilirubin < =1 UNL (patients with a well documented history of Gilbert’s Syndrome are eligible)
ASAT (SGOT) and ALAT (SGPT) < =2.5 UNL
Alkaline phosphatase < =5 UNL
Renal function:
Creatinine <= 175 micromol/L (2 mg/dL)
Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.
Patients must be postmenopausal defined as:
Age >50 y and amenorrheic for 6 months or more
Age <50 y and amenorrheic for 12 months or more
Prior bilateral oophorectomy
Prior hysterectomy and has post menopausal levels of FSH and LH per local institutional standards
Age >55 y and prior hysterectomy

Exclusion Criteria

Prior or concurrent systemic anticancer therapy for breast cancer (immunotherapy, hormone therapy, biological, or chemotherapy).
Prior or concurrent radiation therapy for breast cancer.
Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
M1 breast cancer.
Diabetic patients currenly treated with metformin. Diet controlled diabetic patients are eligible.
Other serious illness or medical condition:
Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias,history of significant neurological or psychiatric disorders including psychotic disorders,
dementia or seizures that would prohibit the understanding and giving of informed consent,
active uncontrolled infection,
active peptic ulcer
Current history of any neoplasm other than breast carcinoma.
Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped at least 4 weeks prior to registration.
Concurrent treatment with other experimental drugs.
Current therapy with any hormonal agent such as raloxifene, tamoxifen or other selective oestrogen receptor modulators (SERMs), either for osteoporosis or prevention. Patients must have discontinued these agents at least four weeks prior to registration.
Known allergy reactions or excipients used in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified