CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (NCT04266249)

🧪 Interventions in This Study

• Docetaxel (DRUG)
• Nab-paclitaxel (DRUG)
• Paclitaxel (DRUG)
• Pertuzumab (BIOLOGICAL)
• Trastuzumab (BIOLOGICAL)
• Trastuzumab Emtansine (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
2. Patient must have histologically confirmed HER2-positive primary invasive breast carcinoma, determined by local testing. The tumor must have either HER2 IHC result of 3+ or HER2/CEP17 ratio \> 2 with \> 4.0 HER2 signals per cell by ISH. Tumors with HER2/CEP17 ISH ratio \< 2 are ineligible, even if HER2 copy number is \> 6, unless HER2 IHC result is 3+.
3. Patients hormone receptor (estrogen receptor \[ER\] and progesterone receptor \[PR\]) status must be known and will be determined by local testing. Patients with either hormone receptor -positive or hormone receptor- negative HER2-positive breast cancer are eligible
4. Patients must have AJCC 8th Edition stage II or IIIa according to anatomic staging table at diagnosis
5. Patients without nodal involvement (cN0) are eligible if T size \> 2.0 cm (T2-3)
6. Patients with nodal involvement (cN1-2) are eligible if T1-3
7. Patients with clinical T4 or N3 disease are not eligible
8. Patient must be willing and able (i.e., have no contraindication) to receive standard adjuvant therapy, consisting of HER2-directed therapy, radiation (if indicated) and endocrine therapy (if ER+) if achieving pCR at surgery
9. Patient with bilateral invasive breast cancers are eligible if both cancers are HER2-positive (as defined in 3.1.3) at least one meets protocol eligibility and neither cancer renders the patient ineligible (i.e. per eligibility 3.1.5)
10. Patients with multiple ipsilateral invasive tumors are eligible as long as all tumors are HER2-positive, and at least one tumor focus meets eligibility criteria (per eligibility 3.1.5). Multiple lesions that appear part of the same index tumor do not require additional biopsy/HER2 testing. Multiple lesions that appear part of the same index tumor do not require additional biopsy/HER2 testing. However, even if biopsy is not deemed necessary, consideration should be given to placing a clip in any lesion that is 1 cm or further from the primary tumor to ensure that all tumor is removed at surgery AND that the pathologist can locate all primary sites of tumor to assess pathologic response at surgery.
11. Patients with a history of other non-breast malignancies are eligible if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy.
12. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, and localized papillary or follicular thyroid cancer who have completed recommended treatment including surgery. Patients with any other cancers within the last 5 years are ineligible.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1008 Sites)

Showing the first 25 of 1008 sites.

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska
• Anchorage Radiation Therapy Center — Anchorage, Alaska
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska
• Alaska Oncology and Hematology LLC — Anchorage, Alaska
• Alaska Women's Cancer Care — Anchorage, Alaska
• Anchorage Oncology Centre — Anchorage, Alaska
• Katmai Oncology Group — Anchorage, Alaska
• Providence Alaska Medical Center — Anchorage, Alaska
• Fairbanks Memorial Hospital — Fairbanks, Alaska
• Kingman Regional Medical Center — Kingman, Arizona
• Cancer Center at Saint Joseph's — Phoenix, Arizona
• University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona
• Banner University Medical Center - Tucson — Tucson, Arizona
• University of Arizona Cancer Center-North Campus — Tucson, Arizona
• Mercy Hospital Fort Smith — Fort Smith, Arkansas
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas
• CARTI Cancer Center — Little Rock, Arkansas
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
• PCR Oncology — Arroyo Grande, California
• Sutter Auburn Faith Hospital — Auburn, California
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Anatomic Stage II Breast Cancer AJCC v8

• T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial — Birmingham, Alabama
• Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer — Columbus, Ohio
• An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial — Rochester, Minnesota
• Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial — Jonesboro, Arkansas
• Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial — Birmingham, Alabama
• Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer — Los Angeles, California

Explore by condition: All Anatomic Stage II Breast Cancer AJCC v8 clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.