Phase 2
N=29
Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer
Breast Cancer · Triple Negative Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03301350 ↗Enrolled (actual)
29
Serious AEs
60.7%
Results posted
Feb 2023
Primary outcome: Primary: Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carboplatin (Drug); Paclitaxel (Drug); Doxorubicin (Drug); Cyclophosphamide (Drug); Pegfilgrastim (Drug); Filgrastim (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate |
8 | — |
| SECONDARY Number of Cycles of Chemotherapy Administered |
25; 3 | — |
| SECONDARY Total Dose of Chemotherapy Administered |
285; 279; 15; 2; 23 | — |
| SECONDARY Delays of Administered Chemotherapy |
12; 7; 3; 4 | — |
| SECONDARY Number of Treatment-related Toxicities Experienced by Participants |
26; 27; 22; 25; 9; 8 | — |
| SECONDARY Recurrence-free Survival (RFS) |
18; 2; 2; 2 | — |
| SECONDARY Overall Survival (OS) |
22; 3 | — |
Summary
This is a phase II single-arm, open-label, prospective study to evaluate the efficacy of the low dose weekly Carboplatin/Paclitaxel followed by dose-dense Doxorubicin/Cyclophosphamide in subjects with triple-negative breast cancer in neoadjuvant settings.
Eligibility Criteria
Inclusion Criteria
- Subjects must have histologically or cytologically confirmed invasive breast cancer which meets the following criteria:
- Estrogen Receptor (ER) and Progesterone Receptor (PR)-negative as defined by local standard clinical immunohistochemistry (IHC) 18 years and grade 1
- Other invasive cancer diagnosis within the past 5 years other than non-melanoma skin cancer.
- Prior axillary lymph node dissection that preclude patient from surgical evaluation of axillary lymph node status.
Data sourced from ClinicalTrials.gov (NCT03301350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.