Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer

NCT02215876 | Withdrawn Phase 2 DMC

• 2 other identifiers: JS14052013/01251
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Her 2-negative breast cancer; neoadjuvant doxorubicin/cyclophosphamide followed by Eribulin chemotherapy

Outcome Measures

Primary Outcomes (1)

• Pathologic Response Rate

  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.

  Estimated 6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Eribulin

Interventions

Doxorubicin DRUG

Doxorubicin 60mg/m2 administered intravenously over 5 minutes on day 1 of a 14 of 21 days cycle IV for 4 cycles

Single Arm

Cyclophosphamide DRUG

Cyclophosphamide 600mg/m2 administered intravenously over 60 minutes on day 1 of a 14 of 21 days cycle IV for 4 cycles

Single Arm

Eribulin DRUG

Eribulin 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of a 21 day cycle for 4 cycles

Single Arm

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• Accessible for treatment and follow-up.
• Baseline cardiac echocardiogram scan with LVEF of ≥ 50%.
• Adequate recovery from recent surgery. At least one week must have elapsed from minor surgery (placement of venous access device or fine needle aspiration) and at least 4 weeks from major surgery.
• Laboratory Parameters
• Absolute neutrophil count (ANC) ≥ 1500/mm3
• Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).

You may not qualify if:

• 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.
• Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocol.
• Clinically significant history of cardiovascular disease (history of unstable angina, congestive heart failure, uncontrolled hypertension, myocardial infarction or valvular heart disease).
• Subjects unfit for breast and/or axillary surgery (complete fixation of tumor, skin infiltration, erythema of the breast, and/or ulceration).
• Current participation in another drug trial.
• Subjects who received prior anthracycline therapy.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Singapore

Singapore, Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; Cyclophosphamide; eribulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Akhil Chopra

  Johns Hopkins Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 13, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: March 1, 2020
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

SG (1)