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The Preoperative Health & Body Study

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

The Preoperative Health & Body Study

Inclusion Criteria:

- Newly diagnosed, histologically confirmed stage I-III breast cancer

- Planning to undergo definitive surgical management with lumpectomy or mastectomy with
in the next 8 weeks.

- Willing and able to participate in the intervention for at least 3 weeks prior to

- ECOG performance status of 0 or 1

- Approval by oncologist or surgeon

- Willingness to be randomized.

- English speaking and able to read English

Exclusion Criteria:

- Concurrent other malignancy or history of other malignancy treated within the past 3
years (other than non-melanoma skin cancer or in situ cervical cancer)

- Presence of metastatic disease

- Scheduled to receive any form of neoadjuvant cancer therapy

- Locally advanced breast cancer not amenable to primary surgery

- History of prior ipsilateral breast cancer

- Taking tamoxifen, raloxifene or an aromatase inhibitor at the time of breast cancer

- Absolute contraindications to maximal exercise testing as recommended by the American
Thoracic Society

- Any condition which in the investigator's opinion makes the subject unsuitable for
study participation

- Participating in another clinical study with competing study outcomes

- Pregnant (i.e., positive beta-HCG) or breast feeding

- Unable to comply with protocol and/or not available for follow-up assessments

- Participation in more than 90 minutes a week of moderate-intensity recreational
activity (not including activities such as gardening, bowling, golfing with a cart)
as assessed by the Leisure Score Index of Godin Leisure- Time Exercise Questionnaire
(LSI) (Appendix I) or recent participation (past 6 months) in two or more strength
training sessions per week.

- Diabetes mellitus requiring insulin or oral agents; patients with diet-controlled
diabetes will be allowed to participate

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Impact of Exercise on Ki-67

Outcome Description:

To explore the impact of exercise upon Ki-67, a tissue-based biomarker associated with breast cancer risk and progression.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jennifer A Ligibel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

August 2011

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I-III breast cancer
  • Breast Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115