An Exploratory Study of Pertuzumab and Trastuzumab in Combination With Palbociclib and Exemestane as Neoadjuvant Therapy for Triple-Positive Breast Cancer

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAnhui Provincial Cancer Hospital

About this trial

This study is a prospective, multicenter, single-arm, exploratory study. A total of 90 patients with early/later-stage triple-positive breast cancer who were scheduled to receive neoadjuvant therapy were recruited. They received neoadjuvant treatment with trastuzumab, pertuzumab, palbociclib, and exemestane in combination. The aim of this study is to evaluate the efficacy and safety of the neoadjuvant treatment regimen of trastuzumab-pertuzumab combined with palbociclib and exemestane in triple-positive breast cancer.

Eligibility criteria

Qualifiers

The tumor stage must be in accordance with the 8th edition of the AJCC standard, being stage II-III for the initial diagnosis;

Pre-menopausal or perimenopausal patients (if this is the case, combined with OFS, which includes bilateral oophorectomy or GnRHa drugs), or post-menopausal patients;

All patients must have been pathologically confirmed as HR+/HER2 receptor positive. The estrogen receptor (ER) is positive (>10%), the progesterone receptor (PR) is positive (>1%), and the HER2 receptor is positive. Follow the 2018 ASCO-CAP HER2 positive interpretation guideline standards. The immunohistochemistry (IHC) score is 3+ or 2+ and the in situ hybridization (ISH) test is positive (ISH amplification rate ≥ 2.0);

Age 18-75 years (inclusive of 18 and 75), female;

Disqualifiers

Has received any form of anti-tumor treatment (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);

Is concurrently receiving other anti-tumor drug treatments;

Stage IV breast cancer;

Breast cancer without pathological tissue diagnosis;

Trial design

Treatments tested in this trial

  • Trastuzumab and Pertuzumab Combination with Palbociclib and Exemestane

Treatment groups

90 Participants
are divided into 1 treatment group

Locations

This trial has no locations