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

Breast Cancer Clinical Trial

— PECP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03756090
• Other study ID #: PECP
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2018
• Source: Zhejiang Cancer Hospital
• Contact: Ding Xiaowen, DR.
• Phone: +86 13588054604
• Email: dingxw[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 30, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. female patients, 18 years = age = 80 years;

2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1

3. Histologically confirmed invasive breast cancer(early stage or locally advanced)

4. HER2 negative (HER2+/- by IHC or FISH-)

5. Hormone receptor (ER and PR) negative

6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)=55% measured by ECHO

7. Signed informed consent form (ICF)

Exclusion Criteria:

1. Metastatic disease (Stage IV) or inflammatory breast cancer

2. Previous or current history of malignant neoplasms, except for curatively treated:

Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.

3. Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension =180/110);

4. Unable or unwilling to swallow capsules.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

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.
• 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.
• Epirubicin
Epirubicin (90mg/m2, D1) cycled every 14 days for the first 4 cycles.
• Cyclophosphamide
Cyclophosphamide (600mg/m2, D1) cycled every 14 days for the first 4 cycles.
• Paclitaxel
Paclitaxel (80mg/m2, D1) cycled every 14 days for the later 4 cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.	Through study completion, an average of 1 year.
Secondary	DFS	Disease-free Survival	Following surgery until Year 3
Secondary	ORR	Objective Response Rate (ORR) during neoadjuvant period	Through study completion, an average of 1 year.
Secondary	AEs	Number and severity of adverse events.Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).	baseline and weekly through 12 months after randomization