Clinical trial · Interventional
Carboplatin, Abraxane, Avastin as Neoadjuvant Therapy for Her2-Negative Breast Cancer
Q3week Carboplatin With Weekly Abraxaneä And Avastin + Subsequent Dose-Dense Ac With Avastin As Neoadjuvant Therapy In Resectable And Unresectable (Stage Iia-Iiib) Her2-Negative Breast Cancer
- 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)
In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in HER2(-) patients was 20%. The investigators' goal is to develop an induction chemotherapy regimen that will have a pCR rate above 30% in patients with HER2(-) disease. Based on a 1-sided 95% confidence interval using normal approximation with an expected pCR rate of at least 35%, approximately 28 patients are required for each cohort. With an assumed pCR rate of at least 35%, the investigators will have approximately 70% statistical power to conclude, with 90% certainty, that the pCR rate with the novel regimen exceeds 20%. The study will accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed 10%.
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
| Avastin | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2\* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks
- interventionNames
- Drug: Abraxane
- Drug: Carboplatin
- Drug: Avastin
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7 Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2\* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility criteria Inclusion criteria: * Histologically documented adenocarcinoma of the breast * ANC \> 1000 cells * Female; age \> 18 * Zubrod PS 0-1 * Platelets \> 100,000 * Stage IIA-IIIB disease * Total bilirubin \< 1.5 ULN * No evidence of any metastatic disease * Serum Creatinine \< 1.5 gm/dl * No prior systemic therapy for breast cancer or Creat Cl \> 30 ml/min * Not pregnant or lactating * Serum ALT \< 2.0 ULN * ER, PR and HER2 status required * LVEF (MUGA/echo WNL) * No baseline \> 2 neuropathy * Urine protein: creat ratio \< 1.0 * HER2-negative - either IHC 0-1+ or FISH ratio \< 2.0 * Hemoglobin \> 9 gm/dl * (FISH testing is required for all HER2 2-3+ tumors by IHC) Exclusion criteria: * No Histologically documented adenocarcinoma of the breast * No-ANC \> 1000 cells * Female; age \< 18 * Zubrod PS \> 0-1 * Platelets \< 100,000 * Stage IV disease * Total bilirubin \> 1.5 ULN * metastatic disease * Serum Creatinine \> 1.5 gm/dl * prior systemic therapy for breast cancer or Creat Cl \> 30 ml/min * pregnant or lactating * Serum ALT \> 2.0 ULN baseline \> 2 neuropathy * Urine protein: creat ratio \>1.0 * HER2-positive * Hemoglobin \< 9 gm/dl
References
Publications (0)
Data not yet available