Trial · NCT07596212
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
NCT07596212, Phase 1, Phase 2, Not yet recruiting, University of Illinois Chicago
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder. Trials, record NCT07596212. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07596212
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
- NCT number
- NCT07596212
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- University of Illinois Chicago
- Conditions
- Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder, Hormone Receptor Positive Breast Carcinoma, Breast Cancer
- Interventions
- Aromatase Inhibitors, Bupropion, GnRH agonist
- First posted
- 2026-05-19
- Last updated
- 2026-08-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder | Until 3 months post-study enrollment | To compare the tolerance of aromatase inhibitor (+/- ovarian suppression therapy) in comparison to aromatase inhibitor (+/- ovarian suppression therapy) plus bupropion. This is assessed by the proportion of patients no longer meeting HSDD criteria as reflected by FSFI \> 26 at three months post-randomization. |
| Secondary | Disease free-survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder | Until 3 years post-study enrollment | To compare the disease free survival rate of patients taking aromatase inhibitor (+/- ovarian suppression therapy) to those taking aromatase inhibitor therapy (+/- ovarian suppression therapy) plus bupropion. This is assessed by the time since treatment end to the date of disease progression, death, or least contact, whichever comes first |
| Secondary | Overall survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder | Until 3 years post-study enrollment | To compare the overall survival rate of patients taking aromatase inhibitor (+/- ovarian suppression therapy) to those taking aromatase inhibitor therapy (+/- ovarian suppression therapy) plus bupropion. This is defined as the time of treatment randomization to death or last contact in study participants. |
| Secondary | Safety and tolerability of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder | Until 6 months post-study enrollment | To determine the safety and tolerability of aromatase inhibitor (+/- ovarian suppression therapy) versus aromatase inhibitor (+/- ovarian suppression therapy) and bupropion as defined by the number of adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5. |
| Secondary | Medication adherence of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder | Until 3 years post-treatment start | To determine the rate of medication adherence for patients taking aromatase inhibitor (+/- ovarian suppression therapy) versus aromatase inhibitor (+/- ovarian suppression therapy) and bupropion. This is defined as the number of medication diary entries and physician queries to treatment. |
| Other | Prevalence and response to treatment of Hypoactive Sexual Desire Disorder in patients with early stage breast cancer across different racial groups | Until 3 years post-treatment start | Prevalence of Hypoactive Sexual Desire Disorder among different racial groups will be assessed by the number of of early breast cancer patients with HSDD who are African-American, Caucasian, and Hispanic while the response to treatment across racial groups will be calculated by the overall decrease in FSFI score for the groups. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07596212
GET https://conductscience.org/api/trials/v1/NCT07596212/registered