Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer

NCT01033032 | Completed Phase 1 Results

• 1 other identifier: SCRI BRE 161
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 16

Brief Summary

Doxorubicin has been an integral part of the treatment of women with breast cancer for many years. Since amrubicin may have more activity than doxorubicin, as well as less cardiotoxicity, evaluation of amrubicin in the treatment of advanced breast cancer should be a priority. In this Phase II study, the investigators propose an evaluation of single-agent amrubicin as second- or third-line treatment for women with metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; Amrubicin

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) of MTD/Phase II Patients

  Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on the study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.

  every 6 weeks until progressive disease

Secondary Outcomes (3)

• Number of Patients With Adverse Events as a Measure of Safety and Tolerability

  every 6 weeks until treatment discontinuation, up to 43 months

• Overall Survival (OS) of MTD/Phase II Patients

  every 6 weeks until treatment discontinuation, up to 43 months

• Overall Response Rate (ORR)

  every 6 weeks until treatment discontinuation, up to 43 months

Study Arms (1)

Amrubicin Phase I/II

EXPERIMENTAL

Systemic therapy with amrubicin

Drug: Amrubicin

Interventions

Amrubicin DRUG

Phase I: dose-escalating portion with the starting dose of amrubicin at 90mg/m\^2 IV q21 days. Dose escalations are as follows: DL2 - 100mg/m\^2; DL3 - 110mg/m\^2; and DL4 - 120mg/m\^2. All cycles are q21 days Phase II: Amrubicin will be administered at the maximum tolerated dose established in Phase I by IV every 21 days

Also known as: Systemic therapy

Amrubicin Phase I/II

Eligibility Criteria

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

You may qualify if:

• Females \>=18 years of age.
• Histologic diagnosis of HER2-negative breast cancer. HER-2 negativity must be confirmed by one of the following:
• FISH-negative (FISH ratio \<2.2), or
• IHC 0-1+, or
• IHC 2-3+ AND FISH-negative (FISH ratio \<2.2)
• Evidence of metastatic or locally advanced, inoperable breast cancer.
• Minimum of 1 and maximum of 2 prior metastatic breast cancer chemotherapy regimens.
• Patients with prior anthracycline therapy are eligible, provided their previous anthracycline was ≥6 months prior to study entry.
• Measurable disease per RECIST criteria version 1.1
• Left ventricular ejection fraction (LVEF) ³50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
• Patients must have QTc interval of \<=450 msec.
• No intercurrent significant medical conditions or cardiac illness.
• Patients must be \>=3 weeks since last chemotherapy, and recovered from all acute toxicities, with the exception of alopecia.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.
• Adequate organ function including the following:

You may not qualify if:

• Any concurrent therapy with other investigational, chemotherapeutic, or hormonal therapy.
• Prior treatment with \>=3 regimens of cytotoxic therapy in the advanced disease setting. (Any number of previous hormonal therapies are acceptable, as long as the therapy is discontinued prior to the patient's enrollment into this study).
• Major surgery or systemic therapy \<=3 weeks of study treatment.
• Prior high-dose chemotherapy requiring hematopoietic stem cell support.
• Prior radiation therapy to \>25% of the bone marrow.
• Uncontrolled brain metastases. Patients with treated brain metastases (resection or radiotherapy) are eligible if brain metastases have responded to treatment as documented by CT or MRI scan obtained at \>=2 weeks after completion of radiation therapy, neurologic symptoms are absent, and steroids have been discontinued.
• Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.
• Diagnosis of second malignancy within the last 3 years (with the exception of carcinoma in situ of the cervix, squamous or basal cell skin cancer, thyroid cancer, ductal carcinoma in situ \[DCIS\], or lobular carcinoma in situ \[LCIS\]).
• Any of the following \<=12 months prior to starting study treatment:
• myocardial infarction;
• severe unstable angina;
• congestive heart failure;
• ongoing cardiac dysrhythmia.
• Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia.
• Patients with previous allergy or hypersensitivity to anthracyclines.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Celgene: collaborator

Study Sites (16)

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Baptist Hospital East

Louisville, Kentucky, 40207, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Hematology Oncology Clinic, LLP

Baton Rouge, Louisiana, 70809, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

National Capital Clinical Research Consortium

Bethesda, Maryland, 20817, United States

Location

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Nebraska Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Portsmouth Regional Hospital

Portsmouth, New Hampshire, 03801, United States

Location

Oncology Hematology Care, Inc

Cincinnati, Ohio, 45242, United States

Location

Berks Hematology Oncology Associates

West Reading, Pennsylvania, 19611, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

amrubicin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John D. Hainsworth, MD
• Organization: Sarah Cannon Research Institute

asksarah@scresearch.net

1-877-691-7274

Study Officials

• Denise A. Yardley, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: December 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2014
• Last Updated: May 3, 2022
• Results First Posted: January 6, 2015

Record last verified: 2022-04

Locations

US (16)