Clinical trial NCT00723125: Carboplatin, Abraxane, Avastin as Neoadjuvant Therapy for Her2-Negative Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2008-07-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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%.

Detailed description: See above brief summary

Eligibility criteria: 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

Primary outcomes:
measure: Pathological Complete Response Rates at Surgery
timeFrame: at surgery approximately 5 months after initial treatment
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 2 years
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale Smilow Cancer Center
state: Connecticut
city: Providence
country: United States
facility: Rhode Island Hsopital
state: Rhode Island
city: Providence
country: United States
facility: Women and Infants
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Brown University
name: William Sikov, MD
role: PRINCIPAL_INVESTIGATOR
References: