ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer (NCT03587740)

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. Participants must have histologically or cytologically confirmed HER2-positive disease by local pathology, defined as immunohistochemistry (IHC) 3+ or amplification by FISH (HER2/CEP17 ratio ≥2 or an average of ≥6 HER2 gene copies per nucleus) AND confirmed by Central Pathology Review (Dr. Deborah Dillon at Brigham and Women's Hospital, Boston, MA) prior to patient being registered to begin protocol therapy. See section 3.4. http://ascopubs.org/doi/full/10.1200/jco.2013.50.9984
2. NOTE: DCIS components should not be counted in the determination of HER2 status.
3. Age ≥60 years at the time of study registration (men and women eligible)
4. Participants must have histologically or cytologically confirmed Stage I-III breast cancer with the following criteria met:
5. If node-negative or if node status unknown (because it was not assessed), tumor must be \>5 mm of any hormone receptor subtype (document ER/PR status: if some ER/PR staining is present, ER and PR negative are defined as being positive in \<10% cells \[per local pathology read\]).
6. If node-positive (N1-N3), T1mi, T1a, T1b, T1c, T2, or T3 tumors are eligible (see below for further details on defining node-negative disease) Definition of node-negative disease (when node status known): If the patient has had a negative sentinel node biopsy and/or a negative axillary dissection, then the patient is determined to be node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H\&E or IHC will be considered node-negative. Any axillary lymph node with tumor clusters between 0.02 and 0.2cm is considered a micrometastasis. Patients with a micrometastasis are eligible even if their tumor is \</= 5mm. An axillary dissection is not required to be performed in patients with a positive sentinel node and management of the axilla will be left up to the treating provider. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the principal investigator will make the final determination as to eligibility. In these special situations, the investigator must document this approval in the patient medical record.
7. ER/PR determination assays performed by IHC methods according to the local institution standard protocol.
8. Standard chemotherapy/trastuzumab declined by patient OR patient is deemed by physician for any reason to not be a candidate for standard therapy (i.e. patient and/or provider choose not to pursue standard trastuzumab-based chemotherapy regimen because of concerns related to toxicity or provider/patient preference).
9. For patients with bilateral or multifocal/multicentric breast cancers, one of the following criteria must be met to enroll: (1) each cancer individually meets criteria for enrollment (only ONE tumor has to undergo central confirmation for HER2), (2) at least one tumor meets eligibility (per tumor size/nodes/subtype outlined above) and the other foci in the ipsilateral or contralateral breast are also HER2-positive but are too small for enrollment (e.g., a patient is eligible if a cancer is T2N0 and HER2-positive in one breast, but the contralateral breast has a T1a HER2+ cancer that isn't eligible on its own, (3) there is at least one qualifying tumor of \>5mm but there are other small foci of disease that are too small to test for ER/PR/HER2 and are felt to be a part of the same tumor or similar tumor, OR (4) at least one tumor meets eligibility and the other foci in the ipsilateral or contralateral breast are HER2-negative and do not meet criteria for adjuvant chemotherapy per provider discretion (e.g. if a patient has a HER2-positive tumor meeting eligibility but also has a second, HER2-negative, small, node-negative, ER+, low grade cancer present, she is still eligible for enrollment). However, in the specific case that a second breast cancer is stage III and HER2-negative, that patient is excluded (because the second cancer is high-risk and likely will require non-HER2-directed therapy).
10. All tumor removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy).
11. NOTE: Management of axillary lymph nodes is up to the treating provider; however, all surgical margins should be clear of invasive cancer or DCIS (i.e., no tumor on ink). The local pathologist must document negative margins of resection in the pathology report. If all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed. Likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed.
12. ≤90 days from the patient's most recent breast surgery for this breast cancer. Note: In cases where registration will occur \>90 days from surgery but within an acceptable time frame, patient may be eligible for enrollment with approval from the PI, Rachel Freedman MD, MPH.

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

📍 All Participating Trial Locations (14 Sites)

• City of Hope Comprehensive Cancer Center — Duarte, California
• The Stamford Hospital — Stamford, Connecticut
• Dana Farber Cancer Institute — Boston, Massachusetts
• Massachusetts General Hospital — Boston, Massachusetts
• Dana-Farber Cancer Institute at St. Elizabeth's Medical Center — Brighton, Massachusetts
• Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center — Milford, Massachusetts
• Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital — South Weymouth, Massachusetts
• Mayo Clinic — Rochester, Minnesota
• Dana-Farber/New Hampshire Oncology-Hematology — Londonderry, New Hampshire
• Memorial Sloan Kettering Cancer Center — New York, New York
• University of North Carolina — Chapel Hill, North Carolina
• Rex Cancer Center — Raleigh, North Carolina
• Lifespan Cancer Institute — Providence, Rhode Island
• Sarah Cannon Research Institute — Nashville, Tennessee

💰 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.