Know Cancer

or
forgot password

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


Phase 2
19 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


See above brief summary

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathological response rates at surgery

Outcome Time Frame:

at surgery approximately 5 months after initail treatment

Safety Issue:

No

Principal Investigator

William Sikov, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brown University

Authority:

United States: Institutional Review Board

Study ID:

BrUOG-BR-211A

NCT ID:

NCT00723125

Start Date:

September 2008

Completion Date:

December 2016

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Bridgeport HospitalBridgeport, Connecticut  06610
The Miriam HospitalProvidence, Rhode Island  02903
Women and InfantsProvidence, Rhode Island  
Yale Smilow Cancer CenterNew Haven, Connecticut  06519
Rhode Island HsopitalProvidence, Rhode Island  02903