To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)

Conditions: Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer

Sex: Female

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE2

Enrollment: 147

Sponsor: ETOP IBCSG Partners Foundation

Summary

This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.

Eligibility Criteria

Inclusion Criteria: 1. Histologically confirmed invasive breast cancer, with the following characteristics: * Early breast cancer with tumor size \>1 cm (as measured by at least one of the required examination methods of clinical examination, mammography and ultrasonography); * No clinical evidence of regional lymph node metastasis (via physical and/or radiological exam) (cN0) OR * Clinical evidence of cN1 status, defined by nodal involvement limited to clinically or radiologically detectable metastasis to movable ipsilateral level I, II axillary lymph node(s) * No evidence of metastasis (M0). 2. Postmenopausal, defined by women with: * Prior bilateral surgical oophorectomy; OR * Amenorrhea and age ≥60 years; OR * Age \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03644186). StuddyBuddy aggregates publicly available trial information.