Trial · NCT07198724
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase II dose (RP2D) | Assessed at the end of the first treatment cycle, Day 21. | The RP2D is defined as the dose at which ≤ 3 out of 12 participants experience Dose Limiting Toxicities (DLT) during the first treatment cycle. |
| Primary | Objective Response Rate (ORR) | assessed for response every 9 weeks (3 cycles) +/- 7 days for the first 27 weeks, then every 12 weeks +/- 7 days, and at end of treatment or start of new anticancer therapy, or up to approximately 24 months | ORR per RECIST 1.1 is defined as the percentage of participants with confirmed complete or partial response as the best overall response. |
| Secondary | ORR in Participants with ESR1-mutant endocrine- and CDK4/6 inhibitor-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer | assessed for response every 9 weeks (3 cycles) +/- 7 days for the first 27 weeks, then every 12 weeks +/- 7 days, and at end of treatment or start of new anticancer therapy, or up to approximately 24 months | ORR per RECIST 1.1 is defined as the percentage of participants with confirmed complete or partial response as the best overall response. |
| Secondary | Clinical Benefit Rate (CBR) | assessed for response every 9 weeks (3 cycles) +/- 7 days for the first 27 weeks, then every 12 weeks +/- 7 days, and at end of treatment or start of new anticancer therapy, or up to approximately 24 months | CBR per RECIST 1.1 is defined as the percentage of participants with confirmed complete or partial response, or stable disease for ≥ 24 weeks as the best overall response |
| Secondary | CBR in Participants with ESR1-mutant endocrine- and CDK 4/6 inhibitor-resistant HR+/HER2-low of HER2-ultralow metastatic cancer | assessed for response every 9 weeks (3 cycles) +/- 7 days for the first 27 weeks, then every 12 weeks +/- 7 days, and at end of treatment or start of new anticancer therapy, or up to approximately 24 months | CBR per RECIST 1.1 is defined as the percentage of participants with confirmed complete or partial response, or stable disease for ≥ 24 weeks as the best overall response |
| Secondary | Median progression-free survival (PFS) | assessed for response/progression every 9 weeks (3 cycles) +/- 7 days for the first 27 weeks, then every 12 weeks +/- 7 days, and at end of treatment or start of new anticancer therapy, or up to approximately 36 months | PFS is defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. |
| Secondary | Median PFS in Participants with ESR1-mutant endocrine- and CDK4/6 inhibitor-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer | assessed for response/progression every 9 weeks (3 cycles) +/- 7 days for the first 27 weeks, then every 12 weeks +/- 7 days, and at end of treatment or start of new anticancer therapy, or up to approximately 36 months | PFS is defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. |
| Secondary | Median Overall Survival (OS) | assessed at all study visits; once progression is documented, subjects will be followed for survival every 6 months from the time of documented progression until participant withdrawal, death, or removal from study, or up to approximately 36 months | OS is defined as the time from registration to death due to any cause. Participants still living are censored at the date last known alive. |
| Secondary | Median OS in Participants with ESR1-mutant endocrine- and CDK4/6 inhibitor-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer | assessed at all study visits; once progression is documented, subjects will be followed for survival every 6 months from the time of documented progression until participant withdrawal, death, or removal from study, or up to approximately 36 months | OS is defined as the time from registration to death due to any cause. Participants still living are censored at the date last known alive. |
| Secondary | Duration of Response (DOR) | assessed for response/progression every 9 weeks (3 cycles) +/- 7 days for the first 27 weeks, then every 12 weeks +/- 7 days, and at end of treatment or start of new anticancer therapy, or up to approximately 36 months | DOR is defined as the time when measurement criteria are met for confirmed complete or partial response (whichever is first recorded) to the first date that recurrent or progressive disease is objectively documented. Participants without response reported are censored at the last disease evaluation. |
| Secondary | DOR in Participants with ESR1-mutant endocrine- and CDK4/6 inhibitor-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer | assessed for response/progression every 9 weeks (3 cycles) +/- 7 days for the first 27 weeks, then every 12 weeks +/- 7 days, and at end of treatment or start of new anticancer therapy, or up to approximately 36 months | DOR is defined as the time when measurement criteria are met for confirmed complete or partial response (whichever is first recorded) to the first date that recurrent or progressive disease is objectively documented. Participants without response reported are censored at the last disease evaluation. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07198724/registered