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NCT07017673 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer
A Phase 2 study of TNBC - Triple-Negative Breast Cancer and Early Stage Triple-Negative Breast Carcinoma, sponsored by Cedars-Sinai Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 4
- Study locations
NCT07017673 is a Phase 2 study of TNBC - Triple-Negative Breast Cancer and Early Stage Triple-Negative Breast Carcinoma that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 34 participants, below the 480-participant average among 22 other TNBC - Triple-Negative Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 4 study locations across 1 state.
The verdict
NCT07017673, a Phase 2 study of TNBC - Triple-Negative Breast Cancer and Early Stage Triple-Negative Breast Carcinoma, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a single arm phase II trial combination of ivonescimab and carbo-docetaxel every 3 weeks for 6 cycles in patients with early-stage triple negative breast cancer. The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant chemotherapy with carboplatin and docetaxel. Patients will receive ivonescimab 20 mg/kg IV on Day 1 of each cycle, and carboplatin AUC6 and docetaxel 75 mg/m2 on Day 1 of each cycle for 6 cycles. Cycles will be 21 days for a total of 6 cycles. Curative intent surgery will be performed within 6 weeks (maximum 12 weeks) time frame upon completion of last dose of chemoimmunotherapy. The surgical pathology information will be used for assessment of pathological response, which serve as the primary endpoint of this study. Patients will undergo assessment at baseline, C1D1 of each cycle and end of treatment visit for collection of treatment-emergent adverse events, evaluated by CTCAE v5.0. Patient reported outcomes will be collected at cycles 1, 4, and 6, and at EOT. All study patients will be followed for at least 5 years for EFS and OS follow up. Research biopsies, peripheral blood and stool samples will be collected at the following time points: baseline, C4D1 (+/-14 days), and surgery (+/-14 days). Baseline and EOT breast MRI will be performed as standard of care for assessment of clinical response. Mid treatment breast ultrasound (C4D1 +/-14 days) will be repeated as standard of care to assess clinical response to treatment. Mid-treatment C4D1 tumor biopsy may be omitted if the primary tumor is no longer visible or the tumor deemed too small for biopsy by radiologist.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Ivonescimab
Study Locations (4)
California
- Cedars-Sinai Medical Center - Los Angeles
- Cedars-Sinai Medical Center Beverly Hills - Los Angeles
- Huntington Cancer Center, an Affiliate of CS Cancer - Pasadena
- Hunt Cancer Institute, an Affiliate of CS Cancer - Torrance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2025-07-25 |
| Est. Completion | 2032-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07017673
The ClinicalTrials.gov registry entry for NCT07017673 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 480-participant average among 22 other TNBC - Triple-Negative Breast Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with TNBC - Triple-Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT07017673 reports 4 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT07017673 about?
NCT07017673 is a clinical study titled "Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer". This is a single arm phase II trial combination of ivonescimab and carbo-docetaxel every 3 weeks for 6 cycles in patients with early-stage triple negative breast cancer. The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant che...
What is the current status of trial NCT07017673?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2025-07-25. Estimated completion is 2032-11.
What conditions does trial NCT07017673 study?
This clinical trial studies the following conditions: TNBC - Triple-Negative Breast Cancer, Early Stage Triple-Negative Breast Carcinoma, TNBC.
What interventions are being tested in trial NCT07017673?
The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Ivonescimab (DRUG).
Who is sponsoring clinical trial NCT07017673?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07017673 being conducted?
This trial has 4 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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