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Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy
Sponsor: Shengjing Hospital
Summary
With the development of neoadjuvant therapy for tumors, neoadjuvant chemotherapy (NAC) has become one of the most common and effective methods for preoperative systemic treatment of locally advanced breast cancer (LABC). Although epirubicin combined with cyclophosphamide and sequential docetaxel has been widely recognized as the first-line NAC for LABC, there are still some inoperable LABCs that are insensitive to chemotherapy and miss the opportunity of surgery, especially those with luminal A and low expression of Ki67. Therefore, neoadjuvant endocrine therapy has important clinical value for such patients. At present, the combination of aromatase inhibitor drugs and cyclin dependent kinase 4/6 can significantly improve the prognosis and survival of LABC compared with aromatase inhibitor monotherapy. However, whether inoperable LABC patients, especially those who are not susceptible to chemotherapy, can choose the combination of aromatase inhibitor drugs and cyclin dependent kinase 4/6 as neoadjuvant endocrine therapy to replace NAC remains unclear. Because the main principle of endocrine therapy is to induce tumor cell cycle arrest, leading to apoptosis of tumor cells, the effect is slower than that of chemotherapy. In addition, whether endocrine therapy can replace chemotherapy as a new adjuvant treatment for patients with inoperable LABC to improve the operability rate has not yet been fully evidenced. Therefore, this trial aims to conduct the prospective randomized controlled phase IV clinical trial of palbociclib combined with letrozole versus epirubicin combined with cyclophosphamide and sequential docetaxel as NAC to prove the efficacy of palbociclib combined with letrozole in postmenopausal estrogen receptor-positive LABC patients with low Ki67 expression.
Official title: Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy for Postmenopausal Estrogen Receptor-positive Breast Cancer: a Prospective Randomized Controlled Double-blind Phase IV Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2021-07-19
Completion Date
2026-05-31
Last Updated
2021-07-20
Healthy Volunteers
No
Conditions
Interventions
palbociclib combined with letrozole
Endocrine group will receive palbociclib combined with letrozole: palbociclib (Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany; license number: H20180040) 125 mg/d, every 28 days as a cycle (medication for 3 consecutive weeks and withdrawal for 1 week); letrozole (Novartis Pharma Schweiz AG, Stein, Switzerland; license number: H20140149) 2.5 mg/d, for 6 consecutive months.
epirubicin combined with cyclophosphamide and sequential docetaxel
Chemotherapy group will receive epirubicin combined with cyclophosphamide and sequential docetaxel: epirubicin (Pfizer Wuxi Pharmaceutical Plant, Wuxi, China; license number: GYZZ H20000496), 90 mg/m2, intravenously, for 120 minutes, once every four weeks, totally four times; cyclophosphamide (Baxter Oncology GmbH, Halle, Germany; license number: H20160468), 600 mg/m2, once every four weeks, totally four times; sequential docetaxel (Sanofi-aventis Deutschland GmbH, Frankfurt am Main, Germany; license number: GYZZ J20150083) 75 mg/m2, intravenously, for 120 minutes, once every four weeks, totally four times.
Locations (1)
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China