Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer

NCT00617942 | Completed Phase 2 Results DMC

• 1 other identifier: BrUOG-BR-211B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;

  These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.

  1 year

Secondary Outcomes (1)

• Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity

  1 year

Study Arms (4)

Neo-adjuvant cohort 1

EXPERIMENTAL

Drug: Cohort 1 neo-adjuvant

Neo-adjuvant cohort 2

EXPERIMENTAL

Drug: Cohort 2 neo-adjuvant

Adjuvant cohort 1

EXPERIMENTAL

Drug: Cohort 1 adjuvant

Adjuvant cohort 2

EXPERIMENTAL

Drug: Cohort 2 adjuvant

Interventions

Cohort 1 neo-adjuvant DRUG

Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14 Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16

Also known as: Abraxane (nab-paclitaxel), Herceptin (trastuzumab) and carboplatin

Neo-adjuvant cohort 1

Cohort 2 neo-adjuvant DRUG

Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16

Neo-adjuvant cohort 2

Cohort 1 adjuvant DRUG

Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians

Adjuvant cohort 1

Cohort 2 adjuvant DRUG

Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians

Adjuvant cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< or = ULN
• No evidence of metastatic disease Not pregnant or lactating
• No prior systemic therapy for this breast cancer
• Serum Creatinine \< 1.5 mg/dl or Creat Cl \> 30 ml/min
• Serum ALT \< 2.5 x ULN
• ER, PR and HER2 status required
• LVEF (MUGA/echo)WNL
• No baseline \> 2 neuropathy
• Hemoglobin \> 9.0 gm/dl
• HER2+, defined by IHC 3+ or FISH ratio \> 2.0

Sponsors & Collaborators

• William Sikov MD: lead
• Yale University: collaborator

Study Sites (5)

City of Hope

Duarte, California, 91010, United States

Location

Yale Smilow Cancer Center

New Haven, Connecticut, 06437, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02903, United States

Location

Roger Williams Medical Center

Providence, Rhode Island, 02908, United States

Location

Rhode Island and The Miriam Hospital

Providence, Rhode Island, 02912, United States

Location

Related Publications (1)

• Cheng H, Bai Y, Sikov W, Sinclair N, Bossuyt V, Abu-Khalaf MM, Harris LN, Rimm DL. Quantitative measurements of HER2 and phospho-HER2 expression: correlation with pathologic response to neoadjuvant chemotherapy and trastuzumab. BMC Cancer. 2014 May 8;14:326. doi: 10.1186/1471-2407-14-326.

  PMID: 24885187 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Trastuzumab; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes

Results Point of Contact

• Title: William Sikov, MD
• Organization: Brown University Oncology Research Group (BrUOG)

BrUOG@brown.edu

4018633000

Study Officials

• William Sikov, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 18, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2015
• Last Updated: June 11, 2020
• Results First Posted: August 22, 2017

Record last verified: 2020-05

Locations

US (5)