Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy

March 26, 2021 updated by: University of Arkansas

This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progression after first line hormonal therapy.

  1. To obtain preliminary estimates of the magnitude and variability of the efficacy of fulvestrant in combination with erlotinib in this subject population, and
  2. To obtain historically up-to-date estimates of the magnitude and variability of the efficacy of fulvestrant as the sole active agent in this subject population.

The measure of efficacy for both primary objectives will be time to progression.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progressed after first line hormonal therapy.

  • Total number of subjects planned for the trial is 130 subjects, that is, approximately 65 subjects in each arm.
  • Subjects will be randomized to receive fulvestrant/erlotinib (arm A) or fulvestrant/placebo (arm B) and stratified based on accrual center.
  • The study is a parallel-arm double-blind study, with fulvestrant + placebo on the monotherapy arm, and fulvestrant + erlotinib on the combination arm.
  • The primary variable outcome is time to progression.
  • Subjects whose metastatic disease was diagnosed more than 12 months after completing adjuvant hormonal therapy are eligible to this study if their breast cancer is hormone-receptor-positive and after disease progression on first line hormonal therapy in the metastatic setting. Subjects may have received no more than one line of chemotherapy. While receiving one line of hormonal therapy in the metastatic setting is a requirement, receiving chemotherapy is not, and one line of chemotherapy in the metastatic setting would not exclude these subjects from the trial. Subjects who had a recurrence while on adjuvant hormonal treatment or within 12 months of completion of the adjuvant hormonal treatment are also eligible without the need to receive first line hormonal therapy in the metastatic setting.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Clinic
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Cancer Institute
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Subjects must sign a written consent.
  2. Subjects must have estrogen- and/or progesterone-receptor-positive histologically confirmed adenocarcinoma of the breast with recurrent or metastatic carcinoma of the breast.
  3. Baseline measurements and evaluations of involved sites should be performed as close as possible to study entry, but must be within 4 weeks prior to randomization.
  4. Subjects fulfilling one of the following criteria are eligible to participate in the study: Subjects with measurable disease as per RECIST criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as over 20 mm with conventional technique or as over 10 mm with spiral CT scan or MRI. Subjects with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria. The lytic component of at least one bone lesion should measure 20 mm with conventional techniques or 10 mm with spiral CT scan or MRI. At least one bone lesion satisfying these criteria must be outside any previously irradiated area.
  5. All subjects must be postmenopausal females defined by:

Prior bilateral oophorectomy OR No menstrual period for 12 months or longer. If age 55 years or less and on tamoxifen within the prior 6 months, must have an estradiol level in the postmenopausal range.

Exclusion Criteria:

1. Subjects must not have had more than 1 prior chemotherapy regimen for metastatic disease and no chemotherapy within 3 weeks prior to randomization. 2. No concurrent chemotherapy is allowed while on protocol therapy. Subjects whose adjuvant hormonal therapy was discontinued more than 12 months ago must have had only 1 prior hormonal therapy for metastatic disease. Subjects who relapsed while receiving adjuvant hormonal therapy or less than 12 months after completing adjuvant hormonal therapy may be enrolled directly in the trial.

3. No prior therapy with an estrogen receptor down-regulator (e.g. fulvestrant). Non-protocol concurrent hormonal therapy is not allowed. Subjects must not have had prior therapy with agents that target EGFR. Previous, but not concomitant, therapy with trastuzumab (Herceptin) is allowed. Subjects must not receive trastuzumab (Herceptin) within 3 weeks prior to randomization.

4. Subjects must have ECOG performance status of 0, 1, or 2. 5. Subjects must have adequate hematologic, hepatic, and renal function defined by the following within 4 weeks prior to randomization: Neutrophils > 1500/mm3 and platelets over 100,000/mm3 Total Bilirubin under 1.25 x Institutional upper limit of normal SGPT (ALT) and SGOT (AST) under 2.5 x Institutional upper limit of normal if no demonstrable liver metastases or under 5 x Institutional upper limit of normal in the presence of liver metastases Calculated creatinine clearance over 30ml/min using the following formula: Ccr = (140 - age in years) times (weight in kgs) times 0.085 72 x serum creatinine in mg/dL INR, PT and PTT under 1.5 x Institutional upper limit of normal.

6. Subjects must not be receiving therapy with anticoagulants or have other contraindication to IM injections.

7. Subjects must be age over 18 years. 8. Subjects must not have a history of central nervous system metastasis. 9. Subjects may receive concurrent radiation therapy to painful sites of bony disease or areas of impending fracture as long as the radiation therapy is initiated prior to study entry and sites of measurable disease outside the radiation therapy port are available to follow.

10. Subjects must not take the following medications while enrolled in this trial: ketoconazole, erythromycin, verapamil.

11. Subjects age less than 55 years must not be receiving LHRH agonists or antagonists within 3 months prior to randomization.

12. Subjects who have an ocular inflammation or infection should be fully treated before entry into the trial.

13. Subjects with a neuropathic keratopathy or diabetes or those with anterior basement membrane disease must be advised of the need for frequent ophthalmologic exams.

14. Subjects who continue to wear contact lenses must be advised that they have an increased risk of ocular events. The decision to wear contact lenses should be discussed with the patient's treating oncologist and ophthalmologist.

15. Subjects must not suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities.

16. Subjects must be disease-free of prior invasive malignancies for over 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 2

Fulvestrant: 250 mg IM Q 4 weeks

Placebo: 150 mg PO QD
Drug: Fulvestrant
Fulvestrant: 250 mg IM Q 4 weeks
Drug: Fulvestrant
250 mg IM Q 4 weeks
Drug: Placebo
Placebo 150 mg PO QD
Active Comparator: 1

Fulvestrant: 250 mg IM Q 4 weeks

Erlotinib: 150 mg PO QD
Drug: Fulvestrant
Fulvestrant: 250 mg IM Q 4 weeks
Drug: Fulvestrant
250 mg IM Q 4 weeks
Drug: erlotinib
150 mg PO QD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Progression-free Survival
Time Frame: through study completion, an average of 3 years
This will be defined as the date from randomization onset to first documented occurrence of PD. Death will be regarded as a progression event in those subjects who die before disease progression. Subjects without documented objective progression at the time of the final analysis will be censored at the date of their last tumor assessment.
through study completion, an average of 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving Either Complete Response or Partial Response
Time Frame: through study completion, an average of 3 years
evaluate response rate and the clinical benefit of fulvestrant alone or in combination with erlotinib
through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arkansas

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
OSI Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 57485
  • UARK 2004-19 (Other Identifier: UAMS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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