Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

July 29, 2015 updated by: Intarcia Therapeutics
The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer in postmenopausal patients with locally advanced or metastatic breast cancer, and whether the side effects of the combination are different from the side effects of letrozole.

Study Overview

Status

Status

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

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

Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens and androgenic precursors in the body. Toremifene blocks circulating and intracellular estrogens from stimulating estrogen receptors in breast cancer cells. The goal of therapy with atamestane, an aromatase inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve maximal suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combination therapy will lengthen the time to disease progression and the rate of objective response compared to single agent aromatase inhibitor therapy with letrozole.

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.
865

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 3

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K 1H 1C4
        • Ottawa Regional Cancer Centre
      • Thunder Bay, Ontario, Canada, P7A7T1
        • Northwestern Ontario Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2W1S6
        • McGill University, Department of Oncology
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Arkhangelsk Regional Oncology Center, Department of Chemotherapy
      • Kazan, Russian Federation, 420029
        • Tatarstan Republican Clinical Oncology Center
      • Krasnodar, Russian Federation, 350040
        • Krasnodar Regional Clinical Oncology Center, Chemotherapy Department
      • Leningrad, Russian Federation, 188663
        • Leningrad Regional Oncology Center
      • Lipetsk, Russian Federation, 398005
        • Lipetsk Regional Oncology Center, Department of General Oncology
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center, Department of Chemotherapy and Combined Treatment of Tumors
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center, Department of Chemotherapy
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center, Department of New Antitumor Drug Research
      • Moscow, Russian Federation, 125284
        • Hertzen Research Institute of Oncology, Department of Chemotherapy
      • Moscow, Russian Federation, 129128
        • Central Clinical Hospital of the Ministry of Transport n.a. Semashko, Department of Chemotherapy
      • Moscow, Russian Federation, 129301
        • Moscow City Hospital #40, Department of Chemotherapy
      • Moscow, Russian Federation, 143423
        • Moscow City Oncology Hospital #62
      • Murmansk, Russian Federation, 183047
        • Murmansk Regional Oncology Center
      • Novosibirsk, Russian Federation, 630047
        • Municipal Clinical Hospital #1, Department of Breast Tumors, Oncology Department
      • Obninsk, Russian Federation, 249036
        • Medical Radiological Research Center
      • Ryazan, Russian Federation, 390046
        • Ryazan Regional Clinical Oncology Center
      • Samara, Russian Federation, 443066
        • Samara Regional Oncology Center, Department of Chemotherapy
      • St. Petersburg, Russian Federation, 197022
        • St. Petersburg City Oncology Center
      • St. Petersburg, Russian Federation, 197089
        • Laboratory of Thoracic Oncology, St. Petersburg Pavlov State Medical University, Research Institute of Pulmonology
      • St. Petersburg, Russian Federation, 197758
        • Petrov Research Institute of Oncology, Department of Biotherapy and Bone Marrow Transplantation
      • St. Petersburg, Russian Federation, 197758
        • Petrov Research Institute of Oncology, Department of Breast Cancer
      • St. Petersburg, Russian Federation, 197758
        • Petrov Research Institute of Oncology, Department of Chemotherapy
      • Stavropol, Russian Federation, 355018
        • Stavropol Regional Oncology Center, Department of Chemotherapy
      • Tomsk, Russian Federation, 634028
        • Research Institute of Oncology, Tomsk Scientific Center, Siberian Department of the Russian Academy of Medical Sciences, Department of Chemotherapy
      • V. Novgorod, Russian Federation, 173016
        • V. Novgorod Regional Oncology Center, Department of Chemotherapy
      • Voronezh, Russian Federation, 394000
        • Burdenko Voronezh Medical Academy, Oncology Department, Clinical Facility: Regional Clinical Oncology Center
  • Ukraine
      • Cherkassy, Ukraine, 18009
        • Cherkassy Regional Oncology Center, Chemotherapy Department
      • Dnepropetrovsk, Ukraine, 49102
        • Dnepropetrovsk State Medical Academy, Oncology Department. Clinical Facility: Dnepropetrovsk City Clinical Hospital #4
      • Donetsk, Ukraine, 83092
        • Donetsk State Medical University. Clinical Facility: Donetsk Regional Antineoplastic Center, Mammology Department
      • Ivano-Frankovsk, Ukraine, 76000
        • Ivano-Frankovsk State Medical Academy; Oncology Department Clinical Facility: Ivano-Frankovsk Regional Oncology Center
      • Kharkov, Ukraine, 61024
        • Kharkov State Medical University. Clinical Facility: Grigoriev Medical Radiology Institute, Chemotherapy Department
      • Kharkov, Ukraine, 61070
        • Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department. Clinical Facility: Kharkov Regional Clinical Oncology Dispensary, Chemotherapy Department
      • Kiev, Ukraine, 01021
        • Kiev Central Clinical Hospital, Ukraine Security Services, Surgery Department
      • Kiev, Ukraine, 03022
        • Kiev Oncology Institute, Ukraine Medical Science Academy, Department of Breast Tumors
      • Kiev, Ukraine, 03115
        • Kiev Postgraduate Studies Medical Academy. Clinical Facility: Kiev City Oncology Hospital, Chemotherapy Department
      • Kiev, Ukraine, 03115
        • National Medical University, Oncology Department. Clinical Facility: Kiev City Oncology Hospital, Surgery Department
      • Krivoy Rog, Ukraine, 50048
        • Krivoy Rog City Oncology Center
      • Lviv, Ukraine, 79031
        • Lviv State Medical University, Oncology and Medical Radiology Department. Clinical Facility: Lviv State Oncology Regional Clinical Diagnostic Center, Chemotherapy Department
      • Odessa, Ukraine, 65055
        • Odessa State Medical University, Oncology Department. Clinical Facility: Odessa Regional Oncology Center, Chemotherapy Department
      • Uzhgorod, Ukraine, 88000
        • Uzhgorod National University Oncology Course of Surgery Department of Postgraduate Education Faculty Clinical Facility: Zakarpatye Regional Oncology Center
      • Zaporozhye, Ukraine, 69104
        • Zaporozhye Statue Institute of Postgraduate Training. Oncology Department; Clinical Facility: Zaporozhye Regional Oncology Center
  • United States
    • Arizona
      • Lake Havasu City, Arizona, United States, 86403
        • Midwest Internal Medicine, PLLC
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
    • California
      • Greenbrae, California, United States, 94904-2007
        • California Cancer Care, Inc.
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Florida
      • Miami Shores, Florida, United States, 33138
        • Innovative Medical Research of South Florida Inc.
    • Georgia
      • Tucker, Georgia, United States, 30084
        • Georgia Cancer Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Maryland Hematology/Oncology Associates
    • Michigan
      • St. Joseph, Michigan, United States, 49085
        • Oncology Care Associates, PLLC
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Oncology and Hematology Group
    • Montana
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic-Oncology West
    • New York
      • New Hartford, New York, United States, 13413
        • Slocum-Dickson Medical Group
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants, Inc.
    • Texas
      • Houston, Texas, United States, 77024
        • Oncology Consultants
      • Killeen, Texas, United States, 76710
        • First Dynamic Healthcare Services, Inc.
    • Utah
      • Logan, Utah, United States, 84341
        • Cache Valley Cancer Treatment & Research Clinic
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
    • Washington
      • Olympia, Washington, United States, 98502
        • Western Washington Oncology Inc., P.S.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women age 18 years or older
  • Pathological or histological confirmation of breast cancer at initial diagnosis or at the time of metastases
  • ECOG performance status of 0, 1 or 2 or Karnofsky performance status of 60 or higher
  • Predicted life expectancy of 12 weeks or more
  • Postmenopausal endocrine status. LH/FSH levels in the postmenopausal range in women whose menopause occurred less than 5 years ago
  • Locally recurrent, locally advanced, locally metastatic disease not amenable to radiation therapy or surgery and/or distant metastatic disease
  • At least one tumor localization measurable in 2 dimensions (one diameter at least 2 cm for soft tissue/visceral disease assessed by CT/MRI scan or conventional X-ray technique, one diameter at least 1 cm for bone lesions assessed by conventional X-ray techniques)
  • Estrogen receptor and/or progesterone receptor positive (by laboratory/institutional standard) at the time of initial diagnosis or determined during subsequent biopsy/surgery of metastases
  • Written informed consent obtained

Exclusion Criteria:

  • Prior hormonal therapy to treat locally recurrent, locally advanced or metastatic disease
  • Prior adjuvant therapy with aromatase inhibitors or antiestrogens/SERMs within 12 months prior to enrollment
  • Progression of disease during therapy with antiestrogens (including SERMs administered for prevention of osteoporosis)
  • Life-threatening locally recurrent, locally advanced or metastatic disease or disease requiring chemotherapeutic intervention (such as inflammatory breast cancer)
  • History of known CNS metastases, significant neurological dysfunction including active seizures, or clinical signs of other significant neurological diseases
  • Other active malignancy (except basal cell carcinoma of the skin or in situ cervical cancer). Patients with previous malignancies must be without evidence of disease for at least five years
  • Renal insufficiency (serum creatinine > 2.0 mg/dL)
  • Aspartate aminotransferase, alanine aminotransferase or serum bilirubin levels more than 2.5 times upper limit of normal
  • Hemoglobin <9 g/dL
  • Platelet count of less than 100,000 platelets per mm3
  • Total white blood cell count of less than 2,000 cells per mm3
  • Premenopausal endocrine status; pregnant or lactating females
  • Usage of an investigational drug within the thirty (30) days prior to enrollment; or the planned usage of an investigational drug other than the study medication during the course of the current study
  • Contraindication to use of toremifene, atamestane, letrozole or any of the inactive components of their formulations
  • Prior enrollment in this study

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: Quadruple

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.
Experimental: Atamestane + toremifene
Drug: atamestane
Drug: toremifene
Drug: aromatase inhibition
Procedure: hormone therapy
Procedure: endocrine therapy
Procedure: antiestrogen therapy
Active Comparator: Letrozole + placebo
Drug: aromatase inhibition
Procedure: hormone therapy
Procedure: endocrine therapy
Drug: letrozole

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
Time Frame
Time to tumor progression
Time Frame: time from randomization to first occurrence of tumor progression, assessed at week 12 and every subsequent 12 weeks for patients continuing in the study for up to approximately 36 months
time from randomization to first occurrence of tumor progression, assessed at week 12 and every subsequent 12 weeks for patients continuing in the study for up to approximately 36 months

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.
Intarcia Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Paul Goss, M.D., Princess Margaret Hospital, Canada

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.
June 1, 2002

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.
January 1, 2006

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.
January 1, 2006

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).
August 23, 2002

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.
August 26, 2002

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.
August 27, 2002

Study Record Updates

Last Update Posted (Estimate)

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.
July 31, 2015

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.
July 29, 2015

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.
July 1, 2015

More Information

Terms related to this study

Keywords

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.
  • Biomed 777-CLP-29

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings