Trial · NCT06607757
Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer
NCT06607757, Phase 2, Recruiting, GBG Forschungs GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer. Trials, record NCT06607757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06607757
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer
- NCT number
- NCT06607757
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- GBG Forschungs GmbH
- Conditions
- CCCA Assessed by Ki67 Drop Below <2.7% From Baseline
- Interventions
- Capivasertib, Fulvestrant injection
- First posted
- 2024-09-23
- Last updated
- 2025-04-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess complete cell cycle arrest (CCCA). | Up to 14 weeks | The primary endpoint CCCA is defined as Ki67 drop to \<2.7% after approximately 10 weeks (will be assessed centrally on the breast tissue submitted to central pathology) |
| Secondary | To asses safety and tolerability | Up to 14 weeks | Tolerability and safety analyses include assessment of patients whose treatment had to be dose reduced, delayed or permanently stopped. |
| Secondary | To assess patholgogical complete response rate (pCR) by different definitions | Up to 14 weeks | Pathological complete response (pCR ypT0 ypN0) is defined as no microscopic evidence of residual invasive and non-invasive viable tumor cells in all resected specimens of the breast and axilla. |
| Secondary | To assess breast conservation rate (BCS) | Up to 14 weeks | BCS is defiened as tumorectomy, segmentectomy or quandrantectomy as the most radical surgery. |
| Secondary | To assess invasive disease-free survival (iDFS) and overall survival (OS) | through study completion, an average of 2 years | iDFS is defined as time from randomization until first iDFS event OS is defined as time from randomization until death due to any cause |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39241495 | BACKGROUND |
Source PubMed
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/NCT06607757
GET https://conductscience.org/api/trials/v1/NCT06607757/registered