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
David Garcia Cinca
Lead sponsor
Hospital Clinic of Barcelona
Sponsor institution
Fundacion Clinic per a la Recerca Biomédica
Collaborator