The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer
NCT ID: NCT03756090
Last Updated: 2018-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-12-01
2020-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental group
Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
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.
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.
Control group
Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
FEMALE
Yes
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Principal Investigators
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Ding Xiaowen, DR.
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Central Contacts
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Other Identifiers
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PECP
Identifier Type: -
Identifier Source: org_study_id