The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer (PECP)
Primary Purpose
Breast Cancer, Breast Diseases, Breast Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Palbociclib
Placebo oral capsule
Epirubicin
Cyclophosphamide
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- female patients, 18 years ≤ age ≤ 80 years;
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer(early stage or locally advanced)
- HER2 negative (HER2+/- by IHC or FISH-)
- Hormone receptor (ER and PR) negative
- Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
- Signed informed consent form (ICF)
Exclusion Criteria:
- Metastatic disease (Stage IV) or inflammatory breast cancer
- 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.
- Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- Unable or unwilling to swallow capsules.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
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.
Outcomes
Primary Outcome Measures
pCR
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
Secondary Outcome Measures
DFS
Disease-free Survival
ORR
Objective Response Rate (ORR) during neoadjuvant period
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).
Full Information
NCT ID
NCT03756090
First Posted
November 25, 2018
Last Updated
December 6, 2018
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03756090
Brief Title
The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Diseases, Breast Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Palbociclib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
Epirubicin (90mg/m2, D1) cycled every 14 days for the first 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide (600mg/m2, D1) cycled every 14 days for the first 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel (80mg/m2, D1) cycled every 14 days for the later 4 cycles.
Primary Outcome Measure Information:
Title
pCR
Description
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
Time Frame
Through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
DFS
Description
Disease-free Survival
Time Frame
Following surgery until Year 3
Title
ORR
Description
Objective Response Rate (ORR) during neoadjuvant period
Time Frame
Through study completion, an average of 1 year.
Title
AEs
Description
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).
Time Frame
baseline and weekly through 12 months after randomization
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
female patients, 18 years ≤ age ≤ 80 years;
Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
Histologically confirmed invasive breast cancer(early stage or locally advanced)
HER2 negative (HER2+/- by IHC or FISH-)
Hormone receptor (ER and PR) negative
Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
Signed informed consent form (ICF)
Exclusion Criteria:
Metastatic disease (Stage IV) or inflammatory breast cancer
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.
Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
Unable or unwilling to swallow capsules.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ding Xiaowen, DR.
Phone
+86 13588054604
Email
dingxw@zjcc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ding Yuqin
Phone
+86 13588255651
Email
13588255651@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding Xiaowen, DR.
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer
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