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A Randomized Phase II, Double Blind, Trial of Standard Chemotherapy With Metformin (vs Placebo) in Women With Metastatic Breast Cancer Receiving First or Second Line Chemotherapy With Anthracycline, Taxane, Platinum or Capecitabine Based Regimens


Phase 2
18 Years
75 Years
Open (Enrolling)
Female
Metastatic Breast Cancer

Thank you

Trial Information

A Randomized Phase II, Double Blind, Trial of Standard Chemotherapy With Metformin (vs Placebo) in Women With Metastatic Breast Cancer Receiving First or Second Line Chemotherapy With Anthracycline, Taxane, Platinum or Capecitabine Based Regimens


Inclusion Criteria:



- Histologically proven invasive breast cancer with metastatic spread outside of
breast, ipsilateral axillary and supraclavicular nodal areas (Histological
confirmation of metastases is not required) OR, Locally advanced breast cancer that
is refractory to initial anticancer treatment.

- A decision has been made to administer single or multiple agent first or second line
chemotherapy that includes one of the following agents: anthracycline, taxane,
platinum, capecitabine.

- Age: 18 to 75 years at the time of registration

- Invasive breast cancer, any ER or PgR status

- ECOG performance status 0-2

- Life expectancy of at least 6 months

- Adequate hepatic and renal function (SGOT and ALT < 1.8 X upper limit of normal for
the institution, alkaline phosphatase ≤ 2X upper limit of normal for the institution,
bilirubin within normal limits for the institution (expect in patients with Gilbert's
syndrome who will be eligible regardless of bilirubin) and creatinine ≤ 130 umol/L)

- Blood counts: Neutrophils must be at least 1,000/mm3 and Platelets ≥ 75,000/mm3.

- Ability to understand and to provide written informed consent for the study

- Absence of any psychological, familial, sociological, or other patient related
factors that might preclude compliance with the study protocol

- Measurable or non measurable (but evaluable) tumour must be present - radiologic or
clinical evaluation must have been performed within 4 weeks prior to registration.

Exclusion Criteria:

- More than one previous line(s) of chemotherapy for metastatic disease - if prior
chemotherapy has been administered, the last date of treatment must have been given
at least 3 weeks prior to registration [any adjuvant systemic treatment is
acceptable]

- If prior hormone therapy (as adjuvant or metastatic therapy) has been administered,
it must have been stopped at least 3 weeks prior to registration

- Radiotherapy to a target or non target lesion within 4 weeks of registration

- Known CNS metastases

- History of cardiac failure

- Known hypersensitivity or allergy to metformin

- History of or known diabetes or baseline fasting glucose ≥ 7.0 mmol/L

- History of lactic or other metabolic acidosis

- Use of metformin within 3 months of registration

- Current or planned pregnancy or lactation in women of child-bearing potential.
Patients of childbearing potential must have a negative serum pregnancy test.

- Fertile patients must agree to use an effective method of contraception while on
study treatment; which could include IUD, condoms or other barrier methods of birth
control

- Habitual alcohol intake of more than three drinks daily

- Concurrent use of any biguanide medication (other than metformin as a study
medication)

- Patients with ≥ grade 2 diarrhea at baseline, malabsorption syndrome or unable to
swallow oral medication

- Previous or concurrent malignancies, except non-melanoma skin cancers, unless
curatively treated and with no evidence of recurrence for ≥ 5 years.

- Use of any investigational agent within 28 days prior to registration.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression free survival.

Outcome Description:

Scans will be repeated every 9 weeks. Local follow up for survival will continue until all patients have died or for a maximum total follow up of 3 years, which ever occurs first. The two study arms will be compared in an intent to treat fashion using Cox proportional hazard analysis, with the stratification variables included in the model. Treatment discontinuation for toxicity or other reasons will be considered an event.

Outcome Time Frame:

From date of randomization to first documented progression or death, which ever occurs first, assessed up to 3 years.

Safety Issue:

No

Principal Investigator

Pamela J Goodwin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai Hospital, New York

Authority:

Canada: Health Canada

Study ID:

OZM-027

NCT ID:

NCT01310231

Start Date:

March 2011

Completion Date:

September 2015

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic Breast Cancer
  • Metformin
  • Breast Neoplasms

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