Fulvestrant as Maintenance Therapy After First-line Chemotherapy in HER2 - Postmenopausal MBC Patients (FUMANCE)

June 14, 2016 updated by: Consorzio Oncotech

Randomized Phase III Study of Fulvestrant as Maintenance Therapy After First-line Chemotherapy in HER2 Negative Postmenopausal Metastatic Breast Cancer Patients

Breast cancer is one of the most prevalent cancers among women, and represents 20 - 25% of all female cancers. Despite earlier diagnosis and improvement in adjuvant therapies, some patients will present metastatic recurrence.

Treatment of breast cancer is determined by the extent of the disease. Early or localized breast cancer is treated by a combination of surgery and radiotherapy. Adjuvant systemic therapy, consisting of chemotherapy and/or endocrine therapy, in tumors deemed hormone responsive, can prolong the disease-free interval and improve overall survival. However, approximately 30% to 40% of patients with early breast cancer will ultimately relapse, with either local recurrence or distant metastases, and require further systemic treatment for advanced disease.

Since breast cancer that recurs or progresses after initial treatment is considered incurable, the therapy options available for advanced disease are concerned with disease control and palliation of symptoms.

Hormonal therapy has become the treatment of choice in postmenopausal women with hormone sensitive breast cancer. Even though the treatment of advanced breast cancer in postmenopausal women has improved with the introduction of agents such as aromatase inhibitors, these agents still have limitations, and disease management continues to be sub-optimal. The use of systemic therapies such as hormonal therapy, chemotherapy or new biological treatment is to reduce tumour masses, improve survival and preserve quality of life. Whatever the initial efficacy of the treatment undertaken in metastatic setting, almost every patient will relapse. The main goal is to improve progression free survival (PFS). To achieve this, the type of chemotherapy, the optimal duration of chemotherapy, the benefit of maintenance chemotherapy, the benefit of maintenance hormonal treatment are debatable.

Study Overview

Status

Status

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

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

The search for prognostic and predictive factors that could influence the survival of patients treated for metastatic breast cancer has already been the subject of several studies. It seems that 2 components in the natural outcome of tumors must be considered. The first category is related to the primary characteristics such as initial histological grade, hormonal receptor status. The second category is linked to the metastatic characteristics: proliferation index reflected by the length of disease-free interval, type and number of metastatic sites involved. On the other hand, some prognostic factors are linked to the treatments undertaken, stressing their impact on the natural outcome of the disease: type of hormonotherapy, type of chemotherapy, type of response achieved by treatment.

The impact of some factors remains debatable, such the duration of treatment. The optimal duration of chemotherapy in patients who respond or have stable disease is not identified.

Definitively, the major limit to the use of prolonged regimens of chemotherapy is related to their toxicity, all the more so as they are cumulative (cardiac toxicity of anthracyclins, neurologic toxicity of taxanes, haematological cumulative toxicities with any chemotherapy…). The proposition to give hormonal treatment to prolong therapy in hormonal-positive tumors is another possible option. In the literature, data focused on this strategy are rare.

One can object that the choice of patient/tumor characteristics for who would or would not receive the maintenance hormonal therapy was not random, or controlled in any way. This may have led to a selection of better prognosis patients. Investigators cannot know whether they are observing natural history or impacting it in such a trial. Nevertheless the major impact obtained by maintenance hormonal treatment after the first line chemotherapy might indicate that this strategy should be recommended in patients with an ER or PgR positive tumor. Based on the amplitude of the benefit observed, it may be ethically debatable to conduct a prospective randomized study. Moreover, randomized trials which assess the benefit of a new chemotherapy regimen should allow the possibility to give maintenance hormonal treatment.

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 (Anticipated)

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.
156

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alessandra Fabi, MD
  • Phone Number: 652666919
  • Email: fabi@ifo.it

Study Contact Backup

Study Locations

  • Italy
      • Ascoli Piceno, Italy
        • Not yet recruiting
        • Ospedale C. e G. Mazzoni di Ascoli Piceno - Area Vasta 5
        • Principal Investigator:
          • Giorgio De signoribus
      • Avezzano, Italy
        • Not yet recruiting
        • P.O. Avezzano Via G. di Vittorio, 6
        • Principal Investigator:
          • Giovanna Amiconi
      • Faenza, Italy
        • Recruiting
        • Ospedale Degli Infermi - Faenza
        • Principal Investigator:
          • Laura Amaducci
      • Foggia, Italy
        • Not yet recruiting
        • A.O.U Ospedali Riuniti di Foggia
        • Principal Investigator:
          • Sante Romito
      • Latina, Italy, 04100
        • Not yet recruiting
        • A.S.L. LT - Ospedale Santa Maria Goretti U.O.C. di Oncologia Medica
        • Principal Investigator:
          • ENZO VELTRI, Md
      • Lecce, Italy, 73100
        • Recruiting
        • Ospedale Vito Fazzi
        • Contact:
          • Mariangela Ciccarese, MD
      • Lucca, Italy
        • Recruiting
        • P.O. Campo di Marte
        • Principal Investigator:
          • Editta Baldini
      • Milano, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Fatebenefratelli e Oftalmico
      • Naples, Italy
        • Recruiting
        • Università di Napoli Federico II Dipartimento di Medicina clinica e Chirurgia
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica
      • Napoli, Italy
        • Recruiting
        • A.O.R.N. "A. Cardarelli"
        • Principal Investigator:
          • Ferdinando Riccardi
      • Ravenna, Italy
        • Recruiting
        • Ospedale di Ravenna
        • Principal Investigator:
          • Amelia Tienghi
      • Roma, Italy, 00144
        • Recruiting
        • Istituto Regina Elena per lo studio e la cura dei tumori S.C. Oncologia Medica A
      • Roma, Italy
        • Not yet recruiting
        • Ospedale fatebenefratelli - Villa S Pietro (Roma)
        • Principal Investigator:
          • Arianna Pellegrino
      • San Benedetto del Tronto, Italy
        • Not yet recruiting
        • Ospedale civile "Madonna del Soccorso" - Area Vasta 5
        • Principal Investigator:
          • Giorgio De signoribus
    • Ancona
      • Fabriano, Ancona, Italy, 60044
        • Not yet recruiting
        • A.S.U.R. Zona Territoriale 6 Fabriano U.O. Oncologia Medica
        • Principal Investigator:
          • Rosa Rita Silva, MD
    • Lucca
      • Lido Di Camaiore, Lucca, Italy, 55041
        • Recruiting
        • Ospedale Unico Versilia U.O. Oncologia Medica
    • MC
      • Mecerata, MC, Italy, 62100
        • Not yet recruiting
        • Presidio Ospedaliero di Macerata
        • Sub-Investigator:
          • Luciano LL Latini, Doctor
    • Pisa
      • Pontedera, Pisa, Italy, 56025
        • Recruiting
        • Ospedale 'Felice Lotti' - Azienda USL 5 di Pisa U.O. di Oncologia Medica
        • Principal Investigator:
          • Giacomo Allegrini, MD
    • Potenza
      • Rionero in vulture, Potenza, Italy, 85028
        • Recruiting
        • Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata U.O. di Oncologia Medica
        • Principal Investigator:
          • Michele Aieta, MD

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Histologically or cytologically diagnosis of breast cancer;
  2. Presence of metastatic disease either measureable or non-measureable but evaluable bone disease as defined by the Response Evaluation Criteria in Solid Tumors;
  3. Diagnosis of hormone receptor positive (HR+), HER2 negative breast cancer. To fulfill the requirement for HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (estrogen receptor [ER], progesterone receptor [PR]). To fulfill the requirement for HER2 negative disease, a breast cancer must not demonstrate over-expression of HER2 by either IHC or fluorescence in-situ hybridization (FISH);
  4. Post-menopausal status at the time of randomization.
  5. Previous treatment with either an antiestrogen or an aromatase inhibitor for adjuvant or metastatic disease is allowed;
  6. Age >18;
  7. One line chemotherapy for metastatic disease discontinued for 21-28 days. Patient has to have response or stability from the first-line chemotherapy. The patient may have received prior systemic chemotherapy in the neo-adjuvant or adjuvant setting;
  8. Patients with measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria;
  9. Performance Status (ECOG) <2;
  10. No brain metastases;
  11. No clinically serious concurrent illnesses;
  12. Adequate organ function
  13. Use of bisphosphonates are allowed;
  14. Use of antiangiogenetic drugs (bevacizumab associated to paclitaxel) is allowed, but discontinued 21-28 days before start study;
  15. Life expectancy > 12 weeks;
  16. Are willing to participate for the duration of the study and to follow study procedures;
  17. Written informed consent prior to any study-specific procedures Written informed consent;

Exclusion Criteria:

  1. Treatment with a drug that has not received regulatory approval for any indication within 21-28 days from the randomization;
  2. Drug (chemotherapy or biological drug) after the end of first-line chemotherapy for maintenance phase;
  3. Significant known cardiovascular impairment (NYHA CHF > grade 2, unstable angina, myocardial infarction within the previous 6 months prior to randomization, or existing serious cardiac arrhythmia). VECF (Ventricular Ejection Cardiac Fraction) ≤ 50%;
  4. Prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization;
  5. Severe/uncontrolled intercurrent illness within the previous 28 days prior to randomization.
  6. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation;
  7. Patients with psychiatric illness, social situation or geographical situation that would preclude informed consent or limit compliance with study requirements, as determined by the Investigator;

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Fulvestrant
In Arm A maintenance Fulvestrant will be given until disease progression, unacceptable toxicity or refused of patient to the treatment.
Drug: Fulvestrant
After randomization patients will receive (Arm A, experimental Arm) fulvestrant as the following schedule: 500 mg i.m. on Days 0, 14, 28 followed by fulvestrant 500 mg im given every 28 days until progression disease. Study will start after 42 days from the last cycle of chemotherapy
Other Names:
  • Faslodex
No Intervention: No intervention
Patients will be randomized to receive fulvestrant (experimental arm) or no treatment

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
Maintenance-progression-free survival (mPFS)
Time Frame: 36 months
Time between the date of randomization and the date of progression or death, whichever occurs first
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.
Consorzio Oncotech

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.
Clinical Research Technology S.r.l.

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: Francesco Cognetti, Regina Elena National Cancer Institute Via Elio Chianesi 53, 00144 Rome, Italy

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.
November 1, 2015

Primary Completion (Anticipated)

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.
September 1, 2017

Study Completion (Anticipated)

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).
February 26, 2015

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.
March 6, 2015

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.
March 9, 2015

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.
June 15, 2016

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.
June 14, 2016

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.
June 1, 2016

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.
  • GIM18-FUMANCE
  • 2014-003798-41 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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