CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
Contrave +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04499950
NCT04499950Phase 2Completed
CompareCT.gov

A Phase II Single Arm Adaptive Weight Loss Study in Women With Early Stage Breast Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Aug 5, 2020·Updated Mar 6, 2025

In Brief

A Phase 2 clinical trial evaluating Contrave and Behavioral Weight Loss for Breast Cancer and Overweight or Obesity. Completed, enrolled 53 participants across 1 site.

Detailed Summary

This is a single arm phase II study designed to determine the effects of pharmacotherapy and a remote behavioral weight loss intervention on weight loss in breast cancer survivors who are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut microbiome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Overweight or Obesity
CountriesUnited States
CollaboratorsAmerican Institute for Cancer Research, Breast Cancer Research Foundation, Hopkins-WellSpan Cancer Research Fund

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 5, 2020
Enrollment StartFeb 8, 2021
Primary CompletionJan 10, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.9 years ago

Interventions

Contravedrug

Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6.

Behavioral Weight Lossbehavioral

6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.