Know Cancer

forgot password

Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer

Phase 3
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer

The primary objective of this trial is to evaluate the effect of the addition of a 2 year,
centrally delivered individualized, telephone-based lifestyle intervention focusing on
weight management to a mailed educational intervention on Disease Free Survival in
post-menopausal women with early stage breast cancer (hormone receptor positive), BMI
≥24-<40 kg/m2, who are receiving standard letrozole adjuvant therapy. The telephone
intervention will involve 19 phone calls, as well as mailings and a participant manual;
women will be asked to lose up to 10% of their weight by reducing their caloric and fat
intake (by 500-1000 kcal/day, 20% calories fat) and increasing their moderate physical
activity (to 150-200 minutes/week). Secondary outcomes include overall survival, distant
disease-free survival, weight change, health-related quality of life (HRQOL), selected
non-cancer medical events and biologic factors (notably insulin). Approximately 2,150 women
will be enrolled; follow-up will continue until target event rates have been met
(anticipated 4-6 years after completion of the intervention). This sample size will provide
80% power (type 1 error 0.05 2-tailed) to detect a hazard ratio (HR) for DFS of 0.74-0.76 in
the weight loss intervention arm.

Inclusion Criteria:

- Post-menopausal woman with a diagnosis of invasive breast cancer (T1-3,pN0-2,M0) for
which definitive surgery was performed during the previous 36 months.

- On adjuvant hormonal therapy with letrozole at time of randomization (either as
initial adjuvant hormonal therapy or after a switch from tamoxifen or other hormonal

- BMI ≥ 24 kg/m2.

- Medical, surgical or radiation oncologist agrees to subject participation in a diet
and physical activity program.

Exclusion Criteria:

- Life expectancy less than five years.

- Self-reported inability to walk at least 2 blocks (at any pace).

- Insulin requiring diabetes (telephone directed diet and physical activity changes
would be difficult in this population without close coordination with the treating
physician). Non-insulin requiring diabetics are eligible for the study.

- Serious digestive and/or absorptive problems, including inflammatory bowel disease
and chronic diarrhea that preclude adherence to the study diet.

- Cardiovascular, respiratory or musculoskeletal disease or joint problems that
preclude moderate physical activity. Moderate arthritis that does not preclude
physical activity is not a reason for ineligibility.

- Psychiatric disorders or conditions that, in the opinion of the investigator, would
preclude participation in the study intervention (e.g. untreated major depression or
psychosis, substance abuse, severe personality disorder).

- Patients on aromatase inhibitors other than letrozole at study entry.

- Known recurrence of breast cancer (local, regional or distant) at any time prior to
study entry.

- History of other malignancies except: adequately treated non-melanoma skin cancer,
curatively treated in situ carcinoma of the cervix, or other solid tumours curatively
treated with no evidence of disease for ≥ 5 years. Prior in situ cancer of the breast
is not a reason for exclusion.

- Patients not fluent in either English or French (spoken and written).

- Patient unwilling or unable to provide informed consent.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Disease-free survival

Outcome Time Frame:

8 years

Safety Issue:


Principal Investigator

Pamela J Goodwin, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

UHN-Mount Sinai Hospital, Toronto, ON


Canada: Health Canada

Study ID:




Start Date:

August 2007

Completion Date:

May 2018

Related Keywords:

  • Breast Cancer
  • lifestyle intervention
  • breast
  • cancer
  • adjuvant
  • letrozole
  • weight loss
  • BMI
  • post-menopausal
  • estrogen receptor positive
  • progesterone receptor positive
  • Breast Neoplasms



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Los Angeles Biomedical (LABIOMED) Research Institue at Harbor-UCLA Medical Center Torrance, California  90502
Beth Israel Deaconess Medical Centre Boston, Massachusetts  02215