Trial · NCT07890597
A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
NCT07890597, Phase 3, Not yet recruiting, Pfizer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer. Trials, record NCT07890597. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07890597
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
- NCT number
- NCT07890597
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 3,800 participants, estimated
- Lead sponsor
- Pfizer
- Conditions
- Early Breast Cancer, Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-)
- Interventions
- Atirmociclib, giredestrant, Atirmociclib placebo
- First posted
- 2026-10-22
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Invasive Breast Cancer Free Survival (iBCFS) | From randomization to first iBCFS event, up to 16 years | iBCFS is defined as the time from the date of randomization to the date of first documented occurrence of invasive ipsilateral breast tumor recurrence, local-regional invasive breast cancer recurrence, invasive contralateral breast cancer, distant recurrence, or death from any cause, as determined by investigator assessment per STEEP v2.0 criteria |
| Secondary | Invasive Disease Free Survival (iDFS) | From randomization to first iDCFS event, up to 16 years | iDFS defined as the time from the date of randomization to the date of first documented occurrence of invasive ipsilateral breast tumor recurrence, local-regional invasive breast cancer recurrence, invasive contralateral breast cancer, distant recurrence, second primary invasive non-breast cancer, or death from any cause, as determined by investigator assessment per STEEP v2.0 criteria |
| Secondary | Disease Recurrence Free Survival (DRFS) | From randomization to first DRFS event, up to 16 years | DRFS as per investigator assessment, defined as the time from the date of randomization to the date of distant recurrence as determined by investigator assessment or death from any cause, whichever occurs first |
| Secondary | Overall survival (OS) | From randomization to death from any cause, up to 16 years | OS is defined as the time from the date of randomization to the date of death due to any cause |
| Secondary | Number and percentage of Participants with Treatment-Emergent Adverse Events (AEs) | From start of treatment until 28 days after last dose of study treatment, up to 5 years | Type, incidence, severity of AE graded by NCI CTCAE v 5.0, seriousness and relationship to study intervention |
| Secondary | Percentage of participants With Clinical Laboratory Abnormalities | From start of treatment until 28 days after last dose of study treatment, up to 5 years | |
| Secondary | Percentage of Participants With ECG abnormalities | From start of treatment until 28 days after last dose of study treatment, up to 5 years | |
| Secondary | Patient Reported Outcomes (PRO) | From start of treatment until 28 days after last dose of study treatment, up to 5 years | Change from baseline in participant reported total score, well-being subscales and symptoms scores and TOI per FACT-ES |
| Secondary | Pre-dose Plasma Concentration (Ctrough) of atirmociclib | Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; Cycle is defined as 28 days |
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/NCT07890597
GET https://conductscience.org/api/trials/v1/NCT07890597/registered