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Metastatic Breast CancerPhase 1/2NCT01033032

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

A Phase 1/2 study testing Amrubicin in people with Metastatic Breast Cancer, run by SCRI Development Innovations, LLC at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Amrubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
16 sitesUnited States
Study dates
Dec 2009to Oct 2014
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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:
  • ANC >=1500 cells/mL
  • Platelet count >=100,000 cells/mL
  • Hemoglobin >=9 g/dL
  • Total bilirubin <=1.5 x ULN; AST/ALT <=2.5 x ULN, (except if due to hepatic metastases, then <=5 x ULN)
  • Serum creatinine <1.5 x ULN
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed <=7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  • Patients must be accessible for treatment and follow-up.
  • Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
  • Patients who are on anticoagulation are acceptable if the therapeutic anticoagulation is stable. Additionally, the patient's INR must be adequate if the patient is receiving treatment with coumadin.
  • Prior hormonal therapy for metastatic breast cancer is permitted; however, the therapy must be discontinued prior to the patient's enrollment in this study.

Who cannot join

  • 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.
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  • 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.
  • Patients who have had a ≥10% drop in LVEF on previous anthracycline therapy.
  • Palliative radiotherapy to areas of metastatic breast cancer must have been completed >7 days prior to the first dose of study treatment. The exception is radiotherapy for brain metastases, which must be completed >=21 days prior to study treatment. (Note: Any measurable lesion that has been previously irradiated will not be considered as a target lesion).
  • Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  • History of seropositive HIV, or patients who are receiving immunosuppressive medications that increase the risk of neutropenic complications.
  • Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  • Use of any non-approved or investigational agent <=30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Hematology Oncology Clinic, LLP

    Baton Rouge, Louisiana, 70809

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • National Capital Clinical Research Consortium

    Bethesda, Maryland, 20817

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio, 45242

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Baptist Hospital East

    Louisville, Kentucky, 40207

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Nebraska Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Portsmouth Regional Hospital

    Portsmouth, New Hampshire, 03801

  • Berks Hematology Oncology Associates

    West Reading, Pennsylvania, 19611

Other trials in United States

About this study

Official title: Phase I/II Trial of Amrubicin as Second- or Third-Line Treatment for Patients With HER2-Negative Metastatic Breast Cancer

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.

Read the detailed description

This will be a phase I/II study where phase I will evaluate the maximum tolerated dose of amrubicin, and phase II will assess the progression free survival of patients with HER2-negative metastatic breast cancer using the dose established in the phase I portion.

Being tested
Amrubicin
Keywords
Metastatic Breast Cancer, Amrubicin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmrubicinDrug

    Also called Systemic therapy

    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

Study groups in NCT01033032
Study groupRoleWhat they receive
Amrubicin Phase I/IIExperimentalSystemic therapy with amrubicin
Receives: Drug: Amrubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: every 6 weeks until progressive disease

Secondary outcomes (3)

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

    Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).

    Measured: every 6 weeks until treatment discontinuation, up to 43 months

  2. Overall Survival (OS) of MTD/Phase II Patients

    Measured from Day 1 of study drug administration to date of death due to any cause. 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 this outcome measure.

    Measured: every 6 weeks until treatment discontinuation, up to 43 months

  3. Overall Response Rate (ORR)

    The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. 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.

    Measured: every 6 weeks until treatment discontinuation, up to 43 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionJul 2013
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01033032
Sponsor's protocol ID
SCRI BRE 161
Status last verified
Apr 2022
First submitted
15 Dec 2009
Last updated
3 May 2022
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Amrubicin in people with Metastatic Breast Cancer, run by SCRI Development Innovations, LLC at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) of MTD/Phase II Patients (time frame: every 6 weeks until progressive disease). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01033032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.

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