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

NCT02383030 | Unknown Phase 3

• 2 other identifiers: GIM18-FUMANCE2014-003798-41
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Keywords

Breast cancer; Metastatic; HER2 negative; postmenopausal; maintenance therapy; fulvestrant

Outcome Measures

Primary Outcomes (1)

• Maintenance-progression-free survival (mPFS)

  Time between the date of randomization and the date of progression or death, whichever occurs first

  36 months

Study Arms (2)

Fulvestrant

EXPERIMENTAL

In Arm A maintenance Fulvestrant will be given until disease progression, unacceptable toxicity or refused of patient to the treatment.

Drug: Fulvestrant

No intervention

NO INTERVENTION

Patients will be randomized to receive fulvestrant (experimental arm) or no treatment

Interventions

Fulvestrant DRUG

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

Also known as: Faslodex

Fulvestrant

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically diagnosis of breast cancer;
• Presence of metastatic disease either measureable or non-measureable but evaluable bone disease as defined by the Response Evaluation Criteria in Solid Tumors;
• 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);
• Post-menopausal status at the time of randomization.
• Previous treatment with either an antiestrogen or an aromatase inhibitor for adjuvant or metastatic disease is allowed;
• Age \>18;
• 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;
• Patients with measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria;
• Performance Status (ECOG) \<2;
• No brain metastases;
• No clinically serious concurrent illnesses;
• Adequate organ function
• Use of bisphosphonates are allowed;
• Use of antiangiogenetic drugs (bevacizumab associated to paclitaxel) is allowed, but discontinued 21-28 days before start study;
• Life expectancy \> 12 weeks;

You may not qualify if:

• Treatment with a drug that has not received regulatory approval for any indication within 21-28 days from the randomization;
• Drug (chemotherapy or biological drug) after the end of first-line chemotherapy for maintenance phase;
• 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%;
• 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;
• Severe/uncontrolled intercurrent illness within the previous 28 days prior to randomization.
• Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation;
• 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;

Sponsors & Collaborators

• Consorzio Oncotech: lead
• Clinical Research Technology S.r.l.: collaborator

Study Sites (20)

A.S.U.R. Zona Territoriale 6 Fabriano U.O. Oncologia Medica

Fabriano, Ancona, 60044, Italy

NOT YET RECRUITING

A.S.L. LT - Ospedale Santa Maria Goretti U.O.C. di Oncologia Medica

Latina, Latina, 04100, Italy

NOT YET RECRUITING

Ospedale Unico Versilia U.O. Oncologia Medica

Lido di Camaiore, Lucca, 55041, Italy

RECRUITING

Presidio Ospedaliero di Macerata

Mecerata, MC, 62100, Italy

NOT YET RECRUITING

Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica

Napoli, Napoli, 80131, Italy

RECRUITING

Ospedale 'Felice Lotti' - Azienda USL 5 di Pisa U.O. di Oncologia Medica

Pontedera, Pisa, 56025, Italy

RECRUITING

Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata U.O. di Oncologia Medica

Rionero in Vulture, Potenza, 85028, Italy

RECRUITING

Istituto Regina Elena per lo studio e la cura dei tumori S.C. Oncologia Medica A

Roma, Roma, 00144, Italy

RECRUITING

Ospedale C. e G. Mazzoni di Ascoli Piceno - Area Vasta 5

Ascoli Piceno, Italy

NOT YET RECRUITING

P.O. Avezzano Via G. di Vittorio, 6

Avezzano, Italy

NOT YET RECRUITING

Ospedale degli Infermi - Faenza

Faenza, Italy

RECRUITING

A.O.U Ospedali Riuniti di Foggia

Foggia, Italy

NOT YET RECRUITING

Ospedale Vito Fazzi

Lecce, 73100, Italy

RECRUITING

P.O. Campo di Marte

Lucca, Italy

RECRUITING

Azienda Ospedaliera Fatebenefratelli e Oftalmico

Milan, Italy

NOT YET RECRUITING

Università di Napoli Federico II Dipartimento di Medicina clinica e Chirurgia

Naples, Italy

RECRUITING

A.O.R.N. "A. Cardarelli"

Napoli, Italy

RECRUITING

Ospedale di Ravenna

Ravenna, Italy

RECRUITING

Ospedale fatebenefratelli - Villa S Pietro (Roma)

Roma, Italy

NOT YET RECRUITING

Ospedale civile "Madonna del Soccorso" - Area Vasta 5

San Benedetto del Tronto, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Francesco Cognetti

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

  STUDY CHAIR

Central Study Contacts

Alessandra Fabi, MD

CONTACT

652666919; fabi@ifo.it

Elena Abrami, BD

CONTACT

info@oncotech.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 9, 2015
• Study Start: November 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 15, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (20)