Overcoming Endocrine Resistance in Metastatic Breast Cancer

NCT02394496 | Unknown Phase 3

• 2 other identifiers: GIM8-OVER2007-006031-30
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 69

Brief Summary

Based on these results it can be envisioned that the majority of endocrine-responsive post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy (front-line, switching or extending) and/or as first-line management of metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Keywords

Fulvestrant; Lapatinib; Aromatase Inhibitor; metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression free survival (PFS): it is defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first.

  Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months

Secondary Outcomes (6)

• Time To Progression

  Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months

• Overall Survival

  Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months

• Response Rate:

  Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months

• Clinical Benefit Rate

  Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 6 months

• Safety as measured by expected and Non-expected toxicity events

  Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months

Study Arms (4)

ARM 1

EXPERIMENTAL

Fulvestrant + Placebo Lapatinib

Drug: Fulvestrant; Drug: Placebo Lapatinib

ARM 2

EXPERIMENTAL

Fulvestrant + Aromatase Inhibitors + Placebo Lapatinib

Drug: Fulvestrant; Drug: Aromatase Inhibitors; Drug: Placebo Lapatinib

ARM 3

EXPERIMENTAL

Fulvestrant + Lapatinib

Drug: Fulvestrant; Drug: Lapatinib

ARM 4

EXPERIMENTAL

Fulvestrant + Lapatinib + Aromatase Inhibitors

Drug: Fulvestrant; Drug: Lapatinib; Drug: Aromatase Inhibitors

Interventions

Fulvestrant DRUG

Fulvestrant 500mg (2 x 5ml) im injections as a loading dose on Day 0, followed by 500mg (2x5ml) on Day 14 (+/- 3 days) , Day 28 (+/- 3 days) and every 28 Days (+/- 3 days) thereafter.

Also known as: Faslodex

ARM 1; ARM 2; ARM 3; ARM 4

Lapatinib DRUG

1500mg (TBD) O.S. qd

ARM 3; ARM 4

Aromatase Inhibitors DRUG

as indicated in the Summary Product Characteristic

Also known as: Aromatase Inhibitor

ARM 2; ARM 4

Placebo Lapatinib DRUG

1500mg (TBD) O.S. qd

Also known as: Placebo

ARM 1; ARM 2

Eligibility Criteria

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

You may qualify if:

• Provision of written informed consent
• Histological/cytological confirmation of breast cancer
• Documented positive hormone receptor status (ER+ve and/or PgR+ve) of primary or metastaic tumor issue, according to the local laboratory parameters
• Postmenopausal women
• Confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors
• Patients demonstrating prior response to AI therapy
• Patients with measurable disease as per RECIST criteria /Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria.
• May have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry;
• Life expectancy of at least 8 months
• WHO performance status 0, 1 or 2
• Patients with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence.
• Are able to swallow and retain oral medication;
• Are able to complete all screening assessments as outlined in the protocol;
• Patients must have normal organ and marrow function
• Left ventricular ejection fraction (LVEF) within the institutional normal range

You may not qualify if:

• Previous therapy with Fulvestrant and/or Lapatinib;
• Patients with HER 2 overexpressing, either IHC 3+ or FISH +;
• Concurrent non study anti-cancer therapy (
• Have unresolved or unstable, serious toxicity from prior administration
• Have malabsorption syndrome,
• Have a concurrent disease or condition that would make the patient inappropriate for study participation,
• Have an active or uncontrolled infection;
• Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
• Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;
• Receive concurrent treatment with an investigational agent or participate in another clinical trial;
• Receive concurrent treatment with prohibited medications
• Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
• Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.

Sponsors & Collaborators

• Consorzio Oncotech: lead

Study Sites (69)

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

Fabriano, Ancona, 60044, Italy

RECRUITING

Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico U.O. Oncologia Medica e Sperimentale

Bari, Bari, 70124, Italy

RECRUITING

Azienda Ospedaliera G. Rummo U.O. di Oncologia Medica

Benevento, Benevento, 82100, Italy

RECRUITING

Ospedale Fatebenefratelli 'Sacro Cuore di Gesù' U.O. Oncologia

Benevento, Benevento, 82100, Italy

RECRUITING

Azienda Ospedaliera Treviglio-Caravaggio U.O. Oncologia Medica

Treviglio, Bergamo, 24047, Italy

RECRUITING

Presidio Ospedaliero 'Antonio Perrino' U.O.C. di Oncologia

Brindisi, Brindisi, 72100, Italy

RECRUITING

dazione di Ricerca e Cura 'Giovanni Paolo II' U.O. di Ginecologia Oncologia

Campobasso, Campobasso, 86100, Italy

RECRUITING

Ospedale Civile di Campobasso - A. Cardarelli U.O.C. Oncologia Medica

Campobasso, Campobasso, 86100, Italy

RECRUITING

Azienda Ospedaliera 'Sant'Anna e San Sebastiano' U.O.C. di Oncologia

Caserta, Caserta, 81100, Italy

RECRUITING

Presidio Ospedaliero Garibaldi - Nesima S.C. di Oncologia Medica

Catania, Catania, 95122, Italy

RECRUITING

A.O.U. Ospedale Vittorio Emanuele e Ferrarotto U.O. di Oncologia Medica

Catania, Catania, 95124, Italy

RECRUITING

Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica

Catania, Catania, 95126, Italy

RECRUITING

Ospedale Civile Renzetti U.O. Oncologia Medica

Lanciano, Chieti, 66034, Italy

RECRUITING

Azienda Ospedaliera S. Anna U.O. di Oncologia Medica

Como, Como, 22100, Italy

RECRUITING

Ospedale S. Francesco da Paola U.O. Oncologia Medica

Paola, Cosenza, 87027, Italy

ACTIVE NOT RECRUITING

Arcispedaliera S. Anna di Ferrara U.O. Oncologia Clinica

Ferrara, Ferrara, 44121, Italy

RECRUITING

IRCCS - 'Casa Sollievo della Sofferenza' U.O. Oncologia Medica

San Giovanni Rotondo, Foggia, 71013, Italy

RECRUITING

Ospedale 'SS. Trinità' U.O. Oncologia Medica

Sora, Frosinone, 03039, Italy

RECRUITING

I.R.C.C.S. A.O.U. San Martino - I.S.T. S.C. Oncologia Medica A

Genova, Genova, 16132, Italy

RECRUITING

ASRM - Ospedale F. Veneziale - Zona di Isernia U.O. Oncologia

Isernia, Isernia, 86170, Italy

RECRUITING

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

Latina, Latina, 04100, Italy

RECRUITING

Ospedale Vito Fazzi U.O. di Oncologia

Lecce, Lecce, 73100, Italy

RECRUITING

Ospedale Unico Versilia U.O. Oncologia Medica

Lido di Camaiore, Lucca, 55041, Italy

RECRUITING

Ospedale Civico San Vincenzo U.O. Oncologia Medica

Taormina, Messina, 98039, Italy

RECRUITING

Istituto Europeo di Oncologia (IRCCS) Dipartimento di Medicina - Unità Cure Mediche

Milan, Milano, 20141, Italy

RECRUITING

Azienda Ospedaliera Cardarelli Divisione Di Oncologia

Napoli, Napoli, 80131, Italy

RECRUITING

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

Napoli, Napoli, 80131, Italy

RECRUITING

Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia

Napoli, Napoli, 80131, Italy

RECRUITING

A.O.U. 'Maggiore della Carità' S.C. Oncologia

Novara, Novara, 28100, Italy

RECRUITING

Istituto Oncologico Veneto - I.R.C.C.S. U.O. di Oncologia Medica II

Padua, Padova, 35128, Italy

RECRUITING

A.O.U.P. 'Paolo Giaccone' U.O.C. di Oncologia Medica

Palermo, Palermo, 90127, Italy

RECRUITING

A.R.N.A.S - Ospedale Civico e Benfratelli G. Di Cristina e M. Ascoli Divisione di Oncologia Medica

Palermo, Palermo, 90127, Italy

RECRUITING

Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II

Pavia, Pavia, 27100, Italy

RECRUITING

IRCCS Policlinico S. Matteo S.C. di Oncologia Medica

Pavia, Pavia, 27100, Italy

ACTIVE NOT RECRUITING

Ospedale S. Maria della Misericordia S.C. Oncologia Medica

Perugia, Perugia, 06122, Italy

RECRUITING

AUSL di Piacenza - Ospedale U.O. Oncologia Medica

Piacenza, Piacenza, 29121, Italy

RECRUITING

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

Pontedera, Pisa, 56025, Italy

RECRUITING

Centro di Riferimento Oncologico S.O.C. di Oncologia Medica C

Aviano, Pordenone, 33081, Italy

RECRUITING

Azienda Ospedaliera Santa Maria degli Angeli U.O. Oncolgia Medica

Pordenone, Pordenone, 33170, Italy

RECRUITING

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

Rionero in Vulture, Potenza, 85028, Italy

RECRUITING

Azienda Ospedaliera Bianchi - Melacrino - Morelli U.O. di Oncologia Medica

Reggio Calabria, Reggio Calabria, 89125, Italy

RECRUITING

Ospedale San Sebastiano Day Hospital Oncologico - Divisione Medicina Acuti

Correggio, Reggio Emilia, 42015, Italy

RECRUITING

Arcispedale S.Maria Nuova Servizio di Oncologia

Reggio Emilia, Reggio Emilia, 42123, Italy

RECRUITING

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

Roma, Roma, 00144, Italy

RECRUITING

Azienda Ospedaliera San Camillo - Forlanini Day Hospital Oncologia Mammella

Roma, Roma, 00149, Italy

RECRUITING

Policlinico Universitario 'Agostino Gemelli' U.O.C. Ginecologia Oncologica

Roma, Roma, 00168, Italy

RECRUITING

Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina U.O. Oncologia

Roma, Roma, 00186, Italy

RECRUITING

Azienda Ospedaliera S. Andrea - Università La Sapienza U.O.C. Oncologia

Roma, Roma, 00189, Italy

RECRUITING

Ospedale San Pietro Fatebenefratelli Dipartimento di Oncologia - Day Hospital Oncologico

Roma, Roma, 00189, Italy

RECRUITING

Azienda Ospedaliera - Ospedale Umberto I U.O. di Medicina e Oncoematologia

Nocera Inferiore, Salerno, 84014, Italy

RECRUITING

Ospedale G. Da Procida - ASL SA U.O. di Oncologia

Salerno, Salerno, 84126, Italy

RECRUITING

Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia

Salerno, Salerno, 84131, Italy

RECRUITING

Presidio Ospedaliero di Vallo della Lucania U.O. Oncologia Medica

Vallo della Lucania, Salerno, 84078, Italy

RECRUITING

Azienda Ospedaliera n. 1 - Annunziata Oncologia Medica

Sassari, Sassari, 07100, Italy

RECRUITING

Università di Sassari U.O. di Oncologia Medica

Sassari, Sassari, 07100, Italy

RECRUITING

AOVV - Ospedale E. Morelli S.O.C. Medicina Interna - D.H. Oncologico-Ematologico-Internistico

Sondalo, Sondrio, 23035, Italy

RECRUITING

Ospedale Civile di Sondrio - Azienda Ospedaliera Valtellina e Valchiavenna S.C. Oncologia Medica

Sondrio, Sondrio, 23100, Italy

RECRUITING

Fondazione del Piemonte per l'Oncologia - Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.) Direzione di Oncologia Medica

Candiolo, Torino, 10060, Italy

RECRUITING

Ospedale Evangelico Valdese - ASL TO1 U.O. di Oncologia Medica

Torino, Torino, 10125, Italy

RECRUITING

Presidio San Lazzaro - A.O.U. San Giovanni Battista di Torino (Molinette) S.C. Oncologia Medica II

Torino, Torino, 10126, Italy

RECRUITING

Università degli Studi di Torino - Ospedale S. Anna U.O. di Oncologia Medica

Torino, Torino, 10126, Italy

RECRUITING

Ospedale Mauriziano Umberto I S.C.D.U. Ginecologia e Ostetricia

Torino, Torino, 10128, Italy

RECRUITING

Centro Oncologico A.S.S. N°1 Triestina Centro Sociale Oncologico

Trieste, Trieste, 34147, Italy

ACTIVE NOT RECRUITING

A.O.U. ´S. Maria della Misericordia´ Dipartimento di Oncologia

Udine, Udine, 33100, Italy

RECRUITING

Ospedale 'S. Antonio Abate' U.O. Oncologia

Gallarate, Varese, 21013, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera Busto Arsizio - Presidio Ospedaliero Saronno S.C. Oncologia Medica

Saronno, Varese, 21047, Italy

RECRUITING

Azienda Ospedaliera Circolo e Fondazione Macchi U.O. di Oncologia Medica

Varese, Varese, 21100, Italy

RECRUITING

Ospedale Sacro Cuore - Don Calabria U.O.C. Oncologia Medica

Negrar, Verona, 37024, Italy

RECRUITING

Presidio Ospedaliero 'Belcolle' U.O.C. Oncologia Medica

Viterbo, Viterbo, 01100, Italy

RECRUITING

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; Lapatinib; Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Sabino De Placido, MD

  Dipartimento di Medicina Clinica e Chirurgia Oncologia Università degli Studi di Napoli "Federico II"

  PRINCIPAL INVESTIGATOR

• Michelino De Laurentiis, MD

  Istituto Nazionale dei Tumori - Fondazione G. Pascale

  STUDY CHAIR

Central Study Contacts

Clinical Research Technology

CONTACT

0039089301545

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: March 20, 2015
• Study Start: November 1, 2007
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

IT (69)