This is a prospective, single arm, open-label, exploratory study in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression), to evaluate the omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab.
Female participants who are at least 40 years of age on the day of signing the informed consent form with histologically confirmed diagnosis of breast cancer.
Not a woman of childbearing potential as defined in protocol OR
A woman of childbearing potential who agrees to follow the contraceptive guidance in protocol during the treatment period and for at least 7 months after the last dose of study treatment
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
A woman of childbearing potential who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior anti-cancer therapy, including investigational agents, or treatment for primary invasive breast cancer.
Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, TDM1 or paclitaxel.
Clinical stage II, III or IV
Single group
Pertuzumab and trastuzumab FDC subcutaneous
DrugPertuzumab and trastuzumab FDC subcutaneous, A loading dose of 1200 mg pertuzumab and 600 mg trastuzumab followed by a maintenance dose of 600 mg pertuzumab and 600 mg; day 1 of each 3 week cycle during 5 neoadjuvant cycles and 13 adjuvant cycles if complete response
Paclitaxel
Drug80 mg/m2, day 1,8,15 of each 3 week cycle during 4 cycles
TDM1
Drug3,6 mg/kg, 14 adjuvant cycles if not complete response
Endocrine therapy
DrugAdjuvant endocrine therapy will be administered as per local practice and according to recognized clinical practice guidelines
Omission surgery
Procedure/SurgeryOmission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab
To estimate the loco-regional invasive disease-free survival of patients who achieve a complete response
To estimate the loco-regional invasive disease-free survival at 3-year of patients who achieve a complete response based on imaging and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery. 3-years loco-regional invasive disease-free survival rate is defined as time from the first date of no disease (i.e., date of stereotaxic guided biopsy) to loco-regional recurrence. Loco-regional recurrence is defined as recurrence of breast cancer in the same breast parenchyma as the original primary lesion, the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast.
To estimate the disease-free survival at 3years of patients who achieve a complete response based on imaging and a stereotaxic guided biopsy and omit loco-regional surgery following neoadjuvant chemotherapy and dual HER2 blockade.
To estimate the disease-free survival at 5 years of patients who achieve a complete response based on imaging and a stereotaxic guided biopsy and omit loco-regional surgery following neoadjuvant chemotherapy and dual HER2 blockade.
To estimate the disease-free survival at 3years of patients who do not achieve a complete response based on imaging following neoadjuvant chemotherapy and dual HER2 blockade
To estimate the disease-free survival at 5 years of patients who do not achieve a complete response based on imaging following neoadjuvant chemotherapy and dual HER2 blockade
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David Garcia Cinca
Lead sponsor
Hospital Clinic of Barcelona
Sponsor institution
Fundacion Clinic per a la Recerca Biomédica
Collaborator
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