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NCT07407920 · ClinicalTrials.gov registry record · Phase 2
Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial
A Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT07407920: Active Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT07407920 is a Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 120 participants, below the 355-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07407920, a Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment (neoadjuvant) therapy and do not have any tumor genetic material (molecular residual disease) circulating in their blood. Standard of care treatment after surgery consists of 1 year of pembrolizumab for patients with triple negative breast cancer or trastuzumab with or without pertuzumab to complete 1 year of treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Lowering the total amount of cancer therapy after breast surgery, may continue to keep the great tumor response to treatment, and may help lower the amount of side effects patients have.
Primary Outcome
Will be independently estimated for each cohort, along with corresponding 95% confidence intervals using Kaplan-Meier method.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- BIOLOGICAL Trastuzumab
- DRUG Hormone Therapy
- BIOLOGICAL Pertuzumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-10-09 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 2 |
What the registry record for NCT07407920 still lists
NCT07407920 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 355-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (66% lower).
The record links to 4 conditions, with Anatomic Stage II Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT07407920 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07407920 about?
NCT07407920 is a clinical study titled "Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial". This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment (neoadjuvant) therapy and do not have any tumor genetic material (molecular...
What is the current status of trial NCT07407920?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-10-09. Estimated completion is 2027-09-30.
What conditions does trial NCT07407920 study?
This clinical trial studies the following conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma, Early Stage HER2-Positive Breast Carcinoma.
What interventions are being tested in trial NCT07407920?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Trastuzumab (BIOLOGICAL), Hormone Therapy (DRUG), Pertuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07407920?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07407920 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07407920's enrollment target sits among peer trials
120 30th of 73 higher than 42 of 73 other Anatomic Stage II Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage II Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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