Phase 2
N=83
Neoadjuvant Treatment With Nab-paclitaxel for Patients With Stage II and III Luminal Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01565499 ↗Enrolled (actual)
83
Serious AEs
7.4%
Results posted
Nov 2020
Primary outcome: Primary: The Residual Cancer Burden Grade III (RCB-III). — 23; 37; 14; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nab-paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Spanish Breast Cancer Research Group
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Residual Cancer Burden Grade III (RCB-III). |
23; 37; 14; 6; 1 | — |
| SECONDARY Pathologic Complete Response (pCR) Rate |
6 | — |
| SECONDARY Objective Response Rate (ORR) by Magnetic Resonance Imaging (MRI) |
62 | — |
| SECONDARY Objective Response Rate (ORR) by Mammogram |
49 | — |
| SECONDARY Invasive Disease Free Survival (IDFS) |
4.89 | — |
| SECONDARY Rate of Conversion to Breast Conserving Surgery (BCS) |
20; 30 | — |
| SECONDARY The Number of Participants Who Experienced Adverse Events (AE) |
81 | — |
| SECONDARY Ki67 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response |
40; 32 | — |
| SECONDARY Caveolin-1 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response |
19; 53 | — |
| SECONDARY Secreted Protein, Acidic, Cysteine-rich (SPARC) in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response |
65; 7; 7; 65 | — |
| SECONDARY Molecular Tumor Subtypes According to St. Gallen Criteria 2013 in Pre-treatment Tumor Samples as Predictive Marker of Nab-paclitaxel Response |
19; 53 | — |
Summary
Multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive human epidermal growth factor receptor 2 (HER2) negative patients amenable to receive neoadjuvant chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Female patients with histologically confirmed diagnosis of primary unilateral invasive early breast cancer with longest tumor size in breast ≥ 2cm, or or = 1.500/mm3 (1.5 x 109/L); platelet count > or = 100.000/mm3 (100.0 x 109/L); and hemoglobin > or = 9 g/dL.
- Hepatic: bilirubin 1 according to the NCI-CTCAE vs 4.03 criteria
- Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry.
- Have any serious concomitant systemic disorder incompatible with the study (at the discretion of investigator).
- Patient is pregnant or breast feeding or planning to become pregnant within the six months after the end of treatment. Women with child-bearing potential must be performed a pregnancy serum or urine testing within 7 days prior to study entry according to institutional standards and should use an adequate non-hormonal contraceptive method (intra-uterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterilized) during treatment with study drugs and within the six months after the end of treatment.
Data sourced from ClinicalTrials.gov (NCT01565499). 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.