NCT03756090

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

December 7, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

November 25, 2018

Last Update Submit

December 6, 2018

Conditions

Breast CancerBreast DiseasesBreast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • pCR

    Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.

    Through study completion, an average of 1 year.

Secondary Outcomes (3)

  • DFS

    Following surgery until Year 3

  • ORR

    Through study completion, an average of 1 year.

  • AEs

    baseline and weekly through 12 months after randomization

Study Arms (2)

Experimental group

EXPERIMENTAL

Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.

Drug: PalbociclibDrug: EpirubicinDrug: CyclophosphamideDrug: Paclitaxel

Control group

PLACEBO COMPARATOR

Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.

Drug: Placebo oral capsuleDrug: EpirubicinDrug: CyclophosphamideDrug: Paclitaxel

Interventions

PalbociclibDRUG

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.

Experimental group
Placebo oral capsuleDRUG

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.

Control group
EpirubicinDRUG

Epirubicin (90mg/m2, D1) cycled every 14 days for the first 4 cycles.

Control groupExperimental group
CyclophosphamideDRUG

Cyclophosphamide (600mg/m2, D1) cycled every 14 days for the first 4 cycles.

Control groupExperimental group
PaclitaxelDRUG

Paclitaxel (80mg/m2, D1) cycled every 14 days for the later 4 cycles.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsBreast Diseases

Interventions

palbociclibEpirubicinCyclophosphamidePaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Ding Xiaowen, DR.

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ding Xiaowen, DR.

CONTACT

+86 13588054604dingxw@zjcc.org.cn

Ding Yuqin

CONTACT

+86 1358825565113588255651@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 28, 2018

Study Start

December 1, 2018

Primary Completion

December 1, 2019

Study Completion

November 30, 2020

Last Updated

December 7, 2018

Record last verified: 2018-11