Clinical trial · Interventional
The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer
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
NCT03756090CI-TRIAL-00036062PECPunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Diseases | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Palbociclib | Drug | Palbociclib | ALIAS |
| Placebo oral capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
- interventionNames
- Drug: Palbociclib
- Drug: Epirubicin
- Drug: Cyclophosphamide
- Drug: Paclitaxel
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
- interventionNames
- Drug: Placebo oral capsule
- Drug: Epirubicin
- Drug: Cyclophosphamide
- Drug: Paclitaxel
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.