This is a multicenter, open-label, single-arm, one-stage, phase II study to assess the efficacy of a chemotherapy-free pathological complete response (pCR)-guided strategy with trastuzumab and pertuzumab (given as a subcutaneous fixed-dose combination) and T-DM1, for patients with previously untreated HER2-positive early breast cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent prior to beginning specific protocol procedures.
✓. Female or male patients ≥ 18 years of age.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Histologically proven invasive carcinoma of the breast.
✓. Tumor size must be between ≥ 5mm and ≤30mm in greatest dimension using breast MRI. Note: Although tumors between ≥ 5mm and ≤ 10mm are not considered target lesions by RECIST v1.1, we will consider these lesions as targets to follow-up.
✓. Patients must have node-negative breast cancer by clinical exam, MRI and ultrasound according to the American Joint Committee on Cancer (AJCC) 8th edition.
✓. Centrally confirmed HER2\[+\] status with IHC score 3+.
✓. Known estrogen receptor (ER) and progesterone receptor (PgR) status prior to study entry that should be performed by immunohistochemical methods according to the local institution standard protocol.
Exclusion criteria
✕. Any previous treatment, including chemotherapy, anti-HER2 therapy, radiation therapy, or ET for invasive breast cancer (except for breast carcinoma in situ of the contralateral breast cancer, in the last five years before treatment initiation in this study).
✕. HER2 disease with IHC score 0, 1+ or 2+ and in situ hybridization (ISH) positive result.
. Evidence of metastatic disease. Note: All patients must be willing to undergo chest and pelvis computed tomography (CT)/MRI scan before enrolment to prove no evidence of metastatic disease. Bone scan will be performed at baseline only if there is suspicion of bone metastases. If a bone scan cannot be performed, an alternative is PET/CT using 18F-labeled sodium fluoride (18F-fluoride PET/CT).
✕. Patients with bilateral breast cancer.
✕. Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances.
✕. History of other malignancy within the last five years prior to first dose of study drug administration, except for curatively treated basal and squamous cell carcinoma of the skin and/or in situ cervical carcinoma.
✕. Uncontrolled hypertension (systolic \> 150 mm Hg and/or diastolic \> 100 mm Hg) despite adequate antihypertensive treatment.
✕. Serious cardiac illness or medical conditions including, but not confined to, the following: