OncoMatch/Clinical Trials/NCT04893109
ATEMPT 2.0: Adjuvant T-DM1 vs TH
Is NCT04893109 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including trastuzumab-emtansine and Trastuzumab SC for breast cancer.
Treatment: trastuzumab-emtansine · Trastuzumab SC · Paclitaxel — This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: * Trastuzumab-emtansine (T-DM1, Kadcyla) * Trastuzumab SC (Herceptin Hylecta) * Paclitaxel
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) amplification (HER2-positive by ASCO CAP 2018 guidelines, confirmed by central testing)
HER2-positive by ASCO CAP 2018 guidelines, confirmed by central testing. NOTE: HER-2 status must be confirmed to be positive by central review by NeoGenomics prior to patient starting protocol therapy.
Disease stage
Required: Stage I (AJCC 8th edition)
Excluded: Stage LOCALLY ADVANCED TUMORS AT DIAGNOSIS, INCLUDING TUMORS FIXED TO THE CHEST WALL, PEAU D'ORANGE, SKIN ULCERATIONS/NODULES, OR CLINICAL INFLAMMATORY CHANGES
HER2-positive Stage I histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mic) breast cancer according to the AJCC 8th edition anatomic staging table.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: hormonal therapy (tamoxifen) — adjuvant
Patients may have received up to 4 weeks of tamoxifen therapy, or other hormonal therapy, for adjuvant therapy for this cancer.
Must have received: oophorectomy — cancer prevention
Prior oophorectomy for cancer prevention is allowed.
Must have received: partial breast radiation — prior to registration
Patients who have undergone partial breast radiation (duration ≤ 14 days) prior to registration are eligible. Partial breast radiation must be completed prior to 2 weeks before starting protocol therapy.
Must have received: investigational agent (window study) — prior to surgery for ≤ 2 weeks
Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤ 2 weeks) are eligible. Patients must have discontinued the investigational agent at least 14 days before participation.
Cannot have received: chemotherapy
History of prior chemotherapy in the past 5 years.
Cannot have received: taxane (paclitaxel)
History of paclitaxel therapy
Cannot have received: whole breast radiation
Patients who have undergone whole breast radiation are not eligible.
Lab requirements
Blood counts
ANC ≥ 1000/mm3, Hemoglobin ≥ 9 g/dl, Platelets ≥ 100,000/mm3
Liver function
Total bilirubin ≤ 1.2mg/dL; AST and ALT ≤ 1.5x Institutional ULN; For patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range. Serum alkaline phosphatase should be ≤ 1.5x Institutional ULN.
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
Adequate bone marrow function: ANC ≥ 1000/mm3, Hemoglobin ≥ 9 g/dl, Platelets ≥ 100,000/mm3; Adequate hepatic function: Total bilirubin ≤ 1.2mg/dL, AST and ALT ≤ 1.5x Institutional ULN, For patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range. Serum alkaline phosphatase should be ≤ 1.5x Institutional ULN; Left ventricular ejection fraction (LVEF) ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCSF Helen Diller Family Comprehensive Cancer Center · San Francisco, California
- Smilow Cancer Hospital Care center at Derby · Derby, Connecticut
- Smilow Cancer Hospital Care center at Fairfield · Fairfield, Connecticut
- Smilow Cancer Hospital Care center at Glastonbury · Glastonbury, Connecticut
- Smilow Cancer Hospital Care center at Greenwich · Greenwich, Connecticut
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04893109 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, taxane, whole breast radiation disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
What disease stage is eligible?
Stage I is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages