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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
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

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

    First Posted
    November 25, 2018
    Last Updated
    December 6, 2018
    Sponsor
    Zhejiang Cancer Hospital
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    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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