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NCT04266249 · ClinicalTrials.gov registry record · Phase 2
CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy
A Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Invasive Breast Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 2,175
- Enrollment target
- 20
- Study locations
NCT04266249: Active Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Invasive Breast Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
NCT04266249 is a Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Invasive Breast Carcinoma that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 2,175 participants, above the 326-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (567% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04266249, a Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Invasive Breast Carcinoma, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 2,175 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, 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. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
Primary Outcome
Events include recurrence of ipsilateral invasive breast tumor, recurrence of locoregional invasive breast tumor, and distant recurrence. Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and estrogen receptor (ER) status. Greenwood method will be used to estimate the 95% confidence interval for 3-year rate.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG Nab-paclitaxel
- PROCEDURE Lumpectomy
- PROCEDURE Mastectomy
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- CARTI Cancer Center - Little Rock
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,175 participants |
| Start Date | 2020-03-13 |
| Est. Completion | 2038-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04266249 still lists
NCT04266249 is an interventional study that assigns participants to a tested intervention. Its 2,175 participants enrollment target places it among the larger protocols in the corpus, above the 326-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (567% higher).
The record links to 9 conditions, with Anatomic Stage II Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT04266249 names 20 study sites across 5 states, led by Alaska, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04266249 about?
NCT04266249 is a clinical study titled "CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy". This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherap...
What is the current status of trial NCT04266249?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 2,175 participants. The study started on 2020-03-13. Estimated completion is 2038-12-31.
What conditions does trial NCT04266249 study?
This clinical trial studies the following conditions: Anatomic Stage II Breast Cancer AJCC v8, Invasive Breast Carcinoma, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8.
What interventions are being tested in trial NCT04266249?
The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Lumpectomy (PROCEDURE), Mastectomy (PROCEDURE).
Who is sponsoring clinical trial NCT04266249?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04266249 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04266249's enrollment target sits among peer trials
2,175 3rd of 73 higher than 71 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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