A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 74
Updated:10/20/2018
Start Date:June 25, 2010
End Date:February 2022

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A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

This study is looking at whether Metformin, an agent that is commonly used to treat diabetes,
can decrease or affect the ability of breast cancer cells to grow and whether Metformin will
work with other therapies to keep cancer from recurring. Health Canada has not approved the
sale or use of Metformin to treat breast cancer, although they have approved its use in this
clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its
use in breast cancer is considered investigational.

OBJECTIVES:

Primary

- To compare invasive disease-free survival of patients with hormone receptor positive
early-stage breast cancer treated with metformin vs placebo in addition to standard
adjuvant therapy.

Secondary

- To compare overall survival of these patients.

- To compare distant disease-free survival of these patients.

- To compare breast cancer-free interval in these patients.

- To compare changes in body mass index in these patients.

- To compare adverse events in these patients.

- To compare other medical endpoints, including a new diagnosis of diabetes mellitus or
cardiovascular hospitalization (including an emergency room visit or overnight stay) or
death (stroke or myocardial infarction), in these patients.

- To compare health-related quality of life measured using the EORTC QLQ-C30 (supplemented
by a trial-specific checklist), the Block Alive Screener, and physical activity items
from the Nurses Health Study Questionnaire II on a subset of these patients.

- To compare embedded correlative science outcomes including plasma insulin and molecular
markers of metformin action in these patients.

- To compare metabolic parameters including metabolic components of the insulin resistance
syndrome as defined by the ATP III criteria in a subset of these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to hormone-receptor
status (estrogen receptor- and/or progesterone receptor- positive vs both receptors
negative), body mass index (≤ 30 vs > 30 kg/m²), HER2 status (positive vs negative), and
prior chemotherapy (any vs none). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral metformin hydrochloride twice daily (once daily in weeks
1-4). Treatment continues for up to 5 years in the absence of disease progression or
unacceptable toxicity.

- Arm II: Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment
continues for up to 5 years in the absence of disease progression or unacceptable
toxicity.

Blood and tumor samples are collected periodically for correlative studies.

Patients may complete quality-of-life, physical activity, and diet questionnaires at baseline
and at 6, 12, 24, 36, 48, and 60 months. (Sub-set of patients).

After completion of study treatment, patients are followed annually.

Eligibility Criteria:

- 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. A core biopsy interpreted as invasive cancer meets this criterion; otherwise,
the date of first histologic diagnosis will be the date of first surgical procedure
that identifies invasive cancer (biopsy, lumpectomy or mastectomy). Neoadjuvant
subjects should have no evidence of clinical T4 disease prior to chemotherapy and
surgery. Bilateral breast carcinoma is allowed provided diagnoses are synchronous -
that is, within 3 months of one another - and at least one of the two breast
carcinomas meet the eligibility criteria and neither violates the eligibility
criteria.

- All subjects (both adjuvant and neo-adjuvant) must have sentinel lymph node biopsy
and/or axillary lymph node dissection.

Sentinel lymph node biopsy alone is allowed in the following instances:

1. sentinel lymph node biopsy is negative: pN0

2. sentinel lymph node biopsy is positive for isolated tumour cells only: pN0 (i+)

3. * clinically node negative, T1-2 tumours with sentinel lymph node biopsy positive in ≤
2 lymph nodes without extra-capsular extension or matted nodes and undergoing breast
conserving surgery and tangential whole breast irradiation (* excludes subjects
treated with neo-adjuvant systemic therapy)

Definitive surgery and/or chemotherapy have been completed at least 4 weeks prior to
randomization. Surgical margins must be clear of invasive carcinoma. If there is
microscopic residual ductal in situ disease present at lumpectomy or total mastectomy
margins, further excision is highly recommended. If further excision is not undertaken, the
subject may still be entered on study, provided that in addition to breast or chest wall
irradiation, a boost to the tumour bed is delivered. In situ lobular disease at the margin
is acceptable.

Adjuvant subjects with the following pT pN combinations are eligible:

- pT1c, pN0 AND negative estrogen and progesterone receptors AND HER2 negative OR

- pT2N0 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 pT3, 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.

- HER2 status must be known. (Positive = 3+ over-expression by IHC in > 30% of invasive
tumour cells OR HER2 gene amplification by FISH/CISH > 6 HER2 gene copies per nucleus,
OR a FISH/CISH ratio: HER2 gene copies to chromosome 17 signals of ≥ 2.2. All other
results will be considered negative).

- 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. (Subjects with bilateral total mastectomies and no
mammogram within 12 months prior to randomization must, instead, have a physical
examination of the chest wall to ensure there is no residual or recurrent disease at
the time of randomization. The date of this examination is used in place of the
mammogram date on the eligibility checklist.)

- Investigations, including chest X-ray or CT chest, bone scan (with radiographs of
suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been
performed between the first histologic diagnosis and the time of randomization.

- Chest X-Ray, 2 view (or Chest CT) is mandatory

- Bone scans (with x-rays of abnormal areas) are required only if there are signs
or symptoms of metastatic disease

- Abdominal imaging is required only if there are signs or symptoms of metastatic
disease

- Hematology investigations (WBC, Granulocytes, Platelets, Hemoglobin) have been
completed within 28 days prior to randomization and results are available.

- Biochemistry investigations have been completed within 28 days prior to randomization
and values are within the parameters required by the protocol.

AST < 1.8 X ULN; ALT < 1.8 X ULN; Alkaline Phosphatase < 2 X ULN; Serum Creatinine < 115
μmol/L (1.3mg/dL) Serum Bilirubin < institution ULN (except for subjects with Gilbert's
Disease who are eligible despite elevated serum bilirubin level)

- ECOG Performance Status of 0,1 or 2 (at baseline evaluation visit within 28 days prior
to randomization).

- Age ≥ 18 and < 75 and life expectancy of at least 5 years (18 years of age was used as
a cut-off due to the lack of data indicating that breast cancer is a health issue in
the < 18 years age group and metformin safety in pediatric patients has not been
confirmed. Age > 80 carries increased risk of lactic acidosis and study intervention
is for 5 years).

- Subjects must be accessible for treatment and follow-up. Investigators must assure
themselves the subjects randomized on this trial will be available for complete
documentation of the treatment, adverse events, and follow-up.

- In accordance with NCIC CTG policy, protocol treatment is to begin within 10 working
days of patient randomization.

- Subject consent must be obtained according to local Institutional and/or University
Human Experimentation Committee requirements. It will be the responsibility of the
local participating investigators to obtain the necessary local clearance, and to
indicate in writing to the NCIC CTG Study Coordinator that such clearance has been
obtained, before the trial can commence in that centre. Because of differing
requirements, a standard consent form for the trial will not be provided but a sample
form is given. A copy of the initial full board REB approval and approved consent form
must be sent to the central office. The patient must sign the consent form prior to
randomization or registration. Please note that the consent form for this study must
contain a statement which gives permission for the NCIC CTG and monitoring agencies to
review patient records (see Section 16 for further details).

For the first 888 eligible English or French-speaking subjects only (sub-set enrollment
completed 2011NOV04):

- Subject is able (i.e. sufficiently fluent) and willing to complete the Quality of Life
(EORTC QLQ C-30 and Trial Specific Checklist) in English or French. The baseline
assessment must already have been completed at the time of enrollment. Inability
(illiteracy in English or French, loss of sight or other equivalent reason) to
complete questionnaires will not make the patient ineligible for the study; however,
ability but unwillingness to complete the questionnaires will make the patient
ineligible. (Once the target number of 888 subjects is achieved, this criterion will
no longer need to be fulfilled.) [See Appendix VI]. Sub-set enrollment completed
2011NOV04.

- English-speaking subjects who have completed the Quality of Life Questionnaire who are
able (i.e. sufficiently fluent) and willing to complete Nurses Health Study II
Physical Activity Questionnaire and Block Alive Screener in English. The baseline
assessment must already have been completed at the time of enrollment. Inability
(illiteracy in English, loss of sight or other equivalent reason) to complete
questionnaires will not make the patient ineligible for the study; however, ability
but unwillingness to complete the questionnaires will make the patient ineligible.
(This component of the study will close at the same time as the Quality Of Life
sub-study.) Closed to new patient enrollment as of 2011NOV04.

Ineligibility Criteria:

- Subjects with a history of other malignancies, except: adequately treated non-melanoma
skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours
curatively treated with no evidence of disease for ≥ 5 years.

- Subjects with locally recurrent or metastatic breast carcinoma. (Subjects with prior
invasive breast cancer at any time are not eligible. Subjects with prior DCIS only in
either breast are eligible provided the DCIS has been curatively treated including
surgery, radiotherapy and/or Tamoxifen).

- Subjects whose axillary node status is unknown.

- Known diabetes (type 1 or 2) or baseline fasting glucose > 7.0 mmol/L (126 mg/dL).
(Sampled and assayed according to local institution's procedures.)

- Known hypersensitivity or intolerance to metformin.

- Any condition associated with increased risk of metformin-associated lactic acidosis
(e.g. congestive heart failure defined as New York Heart Association {NYHA} Class III
or IV functional status [see Appendix IX], history of acidosis of any type; habitual *
Currently taking metformin, sulfonylureas, thiazolidinediones or insulin for any
reason.

- Current or planned pregnancy or lactation in women of child-bearing potential. Men
should not father a child. (An effective method of birth control should be used while
on study treatment which could include abstinence, IUD, condoms or other barrier
methods of birth control because the safety of metformin in pregnancy or in male
fertility has not been established).

- Concurrent or planned participation in randomized trials of weight loss or exercise
interventions or trials targeting insulin, IGF-1 or their receptors, or involving P13K
inhibitors (at the time of randomization)*.

- These interventions would interfere with the primary endpoint. (Also, in general,
double randomizations in breast cancer trials for MA.32 patients are permitted only if
the patient meets all the eligibility criteria for MA.32 and the sponsor of the
previous trial has no objection to the patient also being enrolled in MA.32).
We found this trial at
282
sites
100 E Lancaster Ave
Wynnewood, Pennsylvania 19096
(484) 476-2000
Lankenau Hospital Lankenau Medical Center is one of the Philadelphia region's most trusted and honored...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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8600 Old Georgetown Road
Bethesda, Maryland 20814
301-896-3100
Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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2500 Campus Rd
Honolulu, Hawaii 96822
(808) 956-8111
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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2279 45th Street
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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820 North Chelan Avenue
Wenatchee, Washington 98801
509) 663-8711
Wenatchee Valley Medical Center Established on July 21, 2013, Confluence Health is an affiliation between...
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808 North 39th Avenue
Yakima, Washington 98902
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Akron, Ohio 44304
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
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Albany, Georgia 31701
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Albuquerque, New Mexico 87110
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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Anchorage, Alaska 99508
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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509 Biltmore Ave
Asheville, North Carolina 28801
(828) 213-1111
Mission Hospitals Mission Hospital, the flagship hospital of Mission Health, has been committed to improving...
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13001 E. 17th Pl.
Aurora, Colorado 80045
303-724-5000
University of Colorado Cancer Center - Anschutz Cancer Pavilion The University of Colorado Denver |...
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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489 State St
Bangor, Maine 04401
(207) 973-7000
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Baton Rouge, Louisiana 70809
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Battle Creek, Michigan 49017
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130 Fisher Road
Berlin, Vermont 05602
(802) 225-5400
Mountainview Medical Our medical oncologists, hematologist, and oncology advanced practice nurse, along with other dedicated...
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Bismarck, North Dakota 58501
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900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
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Boca Raton, Florida 33486
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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1300 Morris Park Ave
Bronx, New York 10461
(718) 430-2000
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Brooklyn, New York 11235
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4802 10th Ave
Brooklyn, New York 11219
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
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Burlington, Massachusetts 01805
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2600 Sixth St. SW
Canton, Ohio 44710
330.363.4908
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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200 Hawthorne Ln
Charlotte, North Carolina 28204
(704) 384-4000
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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Charlottesville, Virginia 22901
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232 S Woods Mill Rd
Chesterfield, Missouri 63017
(314) 205-6491
Saint Luke's Hospital St. Luke's Hospital, located in Chesterfield, Missouri, is a regional healthcare provider...
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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Chicago, Illinois 60608
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Chicago, Illinois 60631
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Chicago, Illinois 60625
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Chico, California 95926
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Colorado Springs, Colorado 80903
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Concord, New Hampshire 03301
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Council Bluffs, Iowa 51503
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
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Denver, Colorado 80205
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Duluth, Minnesota 55805
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Edmonton, Alberta
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303 S Nappanee St
Elkhart, Indiana 46514
(574) 296-3200
Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
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500 Arcade Blvd, Ste 240
Elkhart, Indiana 46514
574-389-0414
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155 E. Brush Hill Road
Elmhurst, Illinois 60126
(331) 221-1000
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Evanston, Illinois 60202
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Fairbanks, Alaska 99701
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2601 Broadway
Fargo, North Dakota 58102
(701) 234-2900
Sanford Clinic North-Fargo Sanford Health is an integrated health system headquartered in the Dakotas and...
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Fargo, ND
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801 Broadway
Fargo, North Dakota 58102
(701) 234-6175
Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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Fargo, ND
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Farmington, Connecticut 06030
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Farmington, CT
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555 East Cheves Street
Florence, South Carolina 29506
843-777-2000
McLeod Regional Medical Center McLeod Health, a regional presence and predominant healthcare organization, is dedicated...
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Florence, SC
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Fond Du Lac, Wisconsin 54935
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Fond Du Lac, WI
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2315 E Harmony Rd #110
Fort Collins, Colorado 80528
(970) 212-7600
Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
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Fort Collins, CO
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Fort Collins, CO
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Frederick, Maryland 21701
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Frederick, MD
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550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Unity Hospital Unity Hospital is one of the Twin Cities
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Fridley, MN
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743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
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Gainesville, GA
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Glendale, CA
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298 Washington St
Gloucester, Massachusetts 01930
(978) 283-4000
Addison Gilbert Hospital Addison Gilbert Hospital is a full service, 58-bed medical/surgical acute care facility....
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Gloucester, MA
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