NCT03756090

The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer

A Randomized Study Evaluating the Safety and Effects of the Combination of Palbociclib With Epirubicin and Cyclophosphamide Followed by Paclitaxel as Neoadjuvant Therapy in Triple Negative Breast Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study will look at effects the combination of palbociclib and dose-dense neoadjuvant chemotherapy may have on triple negative breast cancer tumours which have not yet been treated.

Detailed description

Patients will be randomized to one of two treatment arms (1:1 ratio). Dose-Dense neoadjuvant chemotherapy in the first 8 weeks of will be: epirubicin (90mg/m2) and cyclophosphamide (600mg/m2), followed by paclitaxel (80mg / m2) after 8 weeks, cycled every 14 days for total 8 cycles. Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week \[28 days\] cycle. Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks. Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks. Note: Following completion of study therapy, surgery will be scheduled for 18-20 weeks post-randomization. Post-surgical treatment will be at the discretion of treating clinician, following postoperative pathology. After week 16 (end of study therapy) all patients should continue Palbociclib for one year. Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).

Conditions

• Breast Cancer
• Breast Diseases
• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Palbociclib	Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week \[28 days\] cycle.
DRUG	Placebo oral capsule	Placebo oral capsule will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week \[28 days\] cycle.
DRUG	Epirubicin	Epirubicin (90mg/m2, D1) cycled every 14 days for the first 4 cycles.
DRUG	Cyclophosphamide	Cyclophosphamide (600mg/m2, D1) cycled every 14 days for the first 4 cycles.
DRUG	Paclitaxel	Paclitaxel (80mg/m2, D1) cycled every 14 days for the later 4 cycles.

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-12-01
• Completion: 2020-11-30
• First posted: 2018-11-28
• Last updated: 2018-12-07