18 and older, female only, with Breast Cancer or Overweight or Obesity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With 5 Percent Weight Loss (in SLOW-BWL)Primary· 6 months
To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9.
Group
Value
95% CI
SLOW-BWL
16
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable toSecondary· Baseline, 2 months and 6 Months
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function. The total score ranges from 33.5 to 61.7. The higher the score, the better the physical function.
Baseline to 2 months
Group
Value
95% CI
SLOW-BWL
2
0 – 5
FAST-BWL
3
-2 – 6
2 months to 6 months
Group
Value
95% CI
SLOW-BWL
0.0
-0.8 – 3.3
FAST-BWL
1.1
0.0 – 9.0
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable toSecondary· Baseline, 2 months and 6 Months
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference. The total score ranges from 41.0-67.4. The lower the score, the better the pain interference.
Baseline to 2 months
Group
Value
95% CI
SLOW-BWL
-1.1
-4.1 – 1.3
FAST-BWL
0.0
-7.2 – 0.0
2 months to 6 months
Group
Value
95% CI
SLOW-BWL
0.0
-1.3 – 1.3
FAST-BWL
0.0
-4.2 – 0.0
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable toSecondary· Baseline, 2 months and 6 Months
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue. The total score ranges from 39.6 to 62.0. The lower the score, the less the fatigue.
Baseline to 2 months
Group
Value
95% CI
SLOW-BWL Baseline - 2 Months
0.0
-5.0 – 3.2
FAST-BWL Baseline - 2 Months
0.0
-4.1 – 3.9
2 months to 6 months
Group
Value
95% CI
SLOW-BWL Baseline - 2 Months
1.6
-2.0 – 5.3
FAST-BWL Baseline - 2 Months
-0.7
-3.4 – 3.1
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable toSecondary· Baseline, 2 months and 6 Months
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Depression. The total score ranges from 37.1-71.4. The lower the score, the less depression.
Baseline to 2 months
Group
Value
95% CI
SLOW-BWL
0.0
-6.20 – 0.0
FAST-BWL
0.0
-1.50 – 0.80
2 months to 6 months
Group
Value
95% CI
SLOW-BWL
0.0
-2.0 – 0.0
FAST-BWL
-1.8
-8.4 – 0.0
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable toSecondary· Baseline, 2 months and 6 Months
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety. Scores range 36.3-71.5, with higher scores representing more severe anxiety symptoms.
Baseline to 2 months
Group
Value
95% CI
SLOW-BWL
0.0
-3.7 – 1.3
FAST-BWL
0.0
-0.6 – 2.4
2 months to 6 months
Group
Value
95% CI
SLOW-BWL
0
-6 – 2
FAST-BWL
-1
-3 – 1
Change in Scores on the Medical Outcomes Study (MOS) Sexual Functioning Scale Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable toSecondary· Baseline, 2 months and 6 Months
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Medical Outcomes Study (MOS) Sexual Function. Score range 0-100 with higher score indicating less functioning.
Four items are rated on a 5-point scale (1=not a problem, 2=little of a problem, 3=somewhat of a problem, 4=very much of a problem, and 5=not applicable).
Baseline to 2 months
Group
Value
95% CI
SLOW-BWL
0
-9 – 0
FAST-BWL
0
-12 – 0
2 months to 6 months
Group
Value
95% CI
SLOW-BWL
0
0 – 0
FAST-BWL
0
-12 – 0
Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable toSecondary· Baseline, 2 months and 6 Months
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES). Scores ranging from 39.0 to 73.0. Higher scores indicate greater impact from symptoms.
Baseline to 2 months
Group
Value
95% CI
SLOW-BWL
3
-2 – 6
FAST-BWL
2
1 – 4
2 months to 6 months
Group
Value
95% CI
SLOW-BWL
6
0 – 10
FAST-BWL
4
2 – 8
Number of Patients With 5% Weight Loss (in FAST-BWL)Secondary· 6 months
To assess the proportion of women in the FAST-BWL arm who maintain ≥5% weight loss at 6 months.
Group
Value
95% CI
FAST-BWL
13
Adverse events — posted to ClinicalTrials.gov
Time frame: Initiation of drug up to 6 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06809166 — Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity
· Phase 4
· recruiting
NCT03431831 — Assessment of and Treatment Applied to Food Addiction in a Rural Healthy Behaviors Clinic
· Phase 4
· completed
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Currently open trials in the same condition.
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Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 6 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04499950.