Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC

ConditionTriple Negative Breast Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorYale University

About this trial

The purpose of this study is to examine whether a nutrition and exercise program can improve pathologic complete response (pCR) in women with triple-negative breast cancer (TNBC) receiving chemo-immunotherapy before surgery. Pathologic complete (pCR) response means that no cancer in the breast is seen after chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female aged 18 years or older.

Have a diagnosis of stage II or III Triple Negative Breast Cancer (TNBC).

Be scheduled to receive neoadjuvant chemo-immunotherapy.

Be physically able to walk.

Disqualifiers

Having already started a 2nd chemotherapy cycle.

Pregnancy or intention to become pregnant.

Presence of dementia or major psychiatric disease.

Recent (past year) stroke, myocardial infarction, or congestive heart failure.

Trial design

Design model

Parallel

Treatments tested in this trial

Exercise and Medical Nutrition
Behavioral
10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. On weeks counseling is not scheduled an exercise session will be observed.

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: Exercise and Medical NutritionExperimental treatment 1 intervention

Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

Pathologic Complete Response (pCR)

Pathologic Complete Response (pCR) is defined as having no invasive residual disease in the breast or regional lymph nodes after completing neoadjuvant chemotherapy (ypT0 ypN0 or ypT0/is ypN0)

Time frame

Post breast cancer surgery, an average of 6 months

Secondary outcomes

Residual Cancer Burden (RCB)

Residual Cancer Burden (RCB) is a continuous pCR measure.

Time frame

Post breast cancer surgery, an average of 6 months

Other outcomes

Healthy Eating Index (HEI)

Healthy Eating Index (HEI) will be will be estimated using the self-reported food frequency questionnaire developed by Fred Hutchinson Cancer Center.

Time frame

Baseline to end of first line chemotherapy, on average 6 months

Physical activity

Self-reported minutes per week of moderate- to vigorous-intensity physical activity will be estimated using the modifiable physical activity questionnaire.

Time frame

Baseline to end of first line chemotherapy, on average 6 months

Patient reported toxicities

Participants will be asked to complete the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) survey at baseline, 2-months, 4-months and the end of chemotherapy.

Time frame

Baseline to end of first line chemotherapy, on average 6 months

Physical function

Participants will be asked to complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey.

Time frame

Baseline to end of first line chemotherapy, on average 6 months