A Phase II (Single Center) Study of Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 countrySeptember 2014

ConditionsBreast Cancer

InterventionsDoxorubicin Cyclophosphamide Eribulin

DrugsDoxorubicin Cyclophosphamide Eribulin

Overview

Phase: Phase 2
Intervention: Doxorubicin
Conditions: Breast Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations: 1
Primary Endpoint: Pathologic Response Rate
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase II, single institutional study, to evaluate a novel neo-adjuvant regimen in patients with operable, HER2-negative, breast cancer.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

March 2020

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed Written Informed Consent
•Target Population
•Histologically confirmed primary invasive adenocarcinoma of the breast.
•Patients with operable, T2-4, N0-3, M0, T1N1 breast cancer (stage IIA, IIB, IIIA, IIIB and IIIC) with minimum tumor size of 2 cm
•Tumors must be HER-2/neu expression negative, as determined by local hospital laboratory (IHC ≤ 2+ or FISH negative).
•No prior treatment (irradiation, chemotherapy, hormonal, immunotherapy or investigational, etc.) for breast cancer excluding therapy for DCIS. Subjects receiving hormone replacement therapy (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study therapy.
•Subjects who received radiotherapy for DCIS may enroll.
•Disease free of prior malignancy for ≥ 5 years with the exception of curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
•ECOG PS of 0 or
•Accessible for treatment and follow-up.

Exclusion Criteria

•Sex and Reproductive Status
•WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of chemotherapy.
•Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breastfeeding.
•Target Disease Exceptions
•Evidence of metastatic breast cancer following a standard tumor staging work-up.
•Evidence of inflammatory breast cancer.
•Evidence of baseline sensory or motor neuropathy.
•Medical History and Concurrent Diseases
•Known human immunodeficiency viral (HIV) infection.
•Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled or the control of which may be jeopardized by this therapy.

Arms & Interventions

Single Arm

Doxorubucin and Cyclophosphamide q2 or q3 weekly x 4 cycles plus Eribulin on days 1 and 8 of a 21 day cycle x 4 cycles

Intervention: Doxorubicin

Single Arm

Doxorubucin and Cyclophosphamide q2 or q3 weekly x 4 cycles plus Eribulin on days 1 and 8 of a 21 day cycle x 4 cycles

Intervention: Cyclophosphamide

Single Arm

Doxorubucin and Cyclophosphamide q2 or q3 weekly x 4 cycles plus Eribulin on days 1 and 8 of a 21 day cycle x 4 cycles

Intervention: Eribulin

Outcomes

Primary Outcomes

Pathologic Response Rate

Time Frame: Estimated 6 months

To evaluate the pathologic complete response (pCR) rate following neoadjuvant treatment with four cycles of Doxorubicin and Cyclophosphamide (AC) and four cycles of Eribulin mesylate chemotherapy in HER2-negative operable breast cancer.