AzTrials
AzTrials

Metastatic Breast CancerPhase 3OVERNCT02394496

Overcoming Endocrine Resistance in Metastatic Breast Cancer

A Phase 3 study testing Fulvestrant, Lapatinib and Aromatase Inhibitors in people with Metastatic Breast Cancer, run by Consorzio Oncotech at 69 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Fulvestrant, Lapatinib and Aromatase Inhibitors
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
396 participants
Where
69 sitesItaly
Study dates
Nov 2007to Jan 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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,
Show all 13Show fewer
  • 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.

Trial locations and contacts

69 sites in 1 country.

Clinical Research Technology contact

0039089301545

69 sites in 1 country

Italy69 sites, 65 recruiting

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

    Aviano, Pordenone, 33081

    SIMON SPAZZAPAN, Md

    Recruiting

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

    Bari, Bari, 70124

    GIUSEPPE COLUCCI, Md

    Recruiting

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

    Benevento, Benevento, 82100

    BRUNO DANIELE, Md

    Recruiting

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

    Benevento, Benevento, 82100

    ANTONIO FEBBRARO, Md

    Recruiting

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

    Brindisi, Brindisi, 72100

    SAVERIO CINIERI, Md

    Recruiting

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

    Campobasso, Campobasso, 86100

    GABRIELLA MARIA FERRANDINA, Md

    Recruiting

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

    Campobasso, Campobasso, 86100

    FRANCESCO CARROZZA, Md

    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

    Massimo Aglietta, MD

    Massimo Aglietta, MD

    Recruiting

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

    Caserta, Caserta, 81100

    LUIGI DE LUCIA, Md

    Recruiting

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

    Catania, Catania, 95122

    ROBERTO BORDONARO, Md

    Recruiting

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

    Catania, Catania, 95124

    CALOGERO BUSCARINO, Md

    Recruiting

  • Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica

    Catania, Catania, 95126

    MICHELE CARUSO, Md

    Recruiting

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

    Como, Como, 22100

    MONICA GIORDANO, Md

    Recruiting

  • Ospedale San Sebastiano Day Hospital Oncologico - Divisione Medicina Acuti

    Correggio, Reggio Emilia, 42015

    ALESSANDRA ZOBOLI, Md

    Recruiting

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

    Fabriano, Ancona, 60044

    ROSA RITA SILVA, Md

    Recruiting

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

    Ferrara, Ferrara, 44121

    MONICA INDELLI, Md

    Recruiting

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

    Gallarate, Varese, 21013

    Active, not recruiting

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

    Genova, Genova, 16132

    LUCIA DEL MASTRO, Md

    Recruiting

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

    Isernia, Isernia, 86170

    LIBERATO DI LULLO, Md

    Recruiting

  • Ospedale Civile Renzetti U.O. Oncologia Medica

    Lanciano, Chieti, 66034

    ANTONIO NUZZO, Md

    Recruiting

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

    Latina, Latina, 04100

    ENZO VELTRI, Md

    Recruiting

  • Ospedale Vito Fazzi U.O. di Oncologia

    Lecce, Lecce, 73100

    ROSACHIARA FORCIGNANÒ, Md

    Recruiting

  • Ospedale Unico Versilia U.O. Oncologia Medica

    Lido di Camaiore, Lucca, 55041

    Domenico Amoroso, Md

    Recruiting

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

    Milan, Milano, 20141

    FRANCO NOLÈ, Md

    Recruiting

  • Azienda Ospedaliera Cardarelli Divisione Di Oncologia

    Naples, Napoli, 80131

    GIACOMO CARTENÌ, Md

    Recruiting

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

    Naples, Napoli, 80131

    MICHELINO DE LAURENTIIS, Md

    Recruiting

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

    Naples, Napoli, 80131

    SABINO DE PLACIDO, Md

    Recruiting

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

    Negrar, Verona, 37024

    STEFANIA GORI, Md

    Recruiting

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

    Nocera Inferiore, Salerno, 84014

    ALFONSO MARIA D'ARCO, Md

    Recruiting

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

    Novara, Novara, 28100

    Oscar Alabisio, MD

    Recruiting

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

    Padova, Padova, 35128

    ANTONIO JIRILLO, Md

    Recruiting

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

    Palermo, Palermo, 90127

    ANTONIO RUSSO, Md

    Recruiting

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

    Palermo, Palermo, 90127

    VITA LEONARDI, Md

    Recruiting

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

    Paola, Cosenza, 87027

    Active, not recruiting

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

    Pavia, Pavia, 27100

    ANTONIO BERNARDO, Md

    Recruiting

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

    Pavia, Pavia, 27100

    Active, not recruiting

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

    Perugia, Perugia, 06122

    CARLO BASURTO, Md

    Recruiting

  • AUSL di Piacenza - Ospedale U.O. Oncologia Medica

    Piacenza, Piacenza, 29121

    LUIGI CAVANNA, Md

    Recruiting

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

    Pontedera, Pisa, 56025

    Giacomo Allegrini, MD

    Recruiting

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

    Pordenone, Pordenone, 33170

    SILVANA SARACCHINI, Md

    Recruiting

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

    Reggio Calabria, Reggio Calabria, 89125

    MARIO NARDI, Md

    Recruiting

  • Arcispedale S.Maria Nuova Servizio di Oncologia

    Reggio Emilia, Reggio Emilia, 42123

    CORRADO BONI, Md

    Recruiting

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

    Rionero in Vulture, Potenza, 85028

    Michele Aieta, MD

    Recruiting

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

    Roma, Roma, 00144

    FRANCESCO COGNETTI, mD

    Recruiting

  • Azienda Ospedaliera San Camillo - Forlanini Day Hospital Oncologia Mammella

    Roma, Roma, 00149

    ANNA MARIA PARISI, Md

    Recruiting

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

    Roma, Roma, 00168

    GIOVANNI SCAMBIA, Md

    Recruiting

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

    Roma, Roma, 00186

    ANGELO FEDELE SCINTO, Md

    Recruiting

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

    Roma, Roma, 00189

    PAOLO MARCHETTI, Md

    Recruiting

  • Ospedale San Pietro Fatebenefratelli Dipartimento di Oncologia - Day Hospital Oncologico

    Roma, Roma, 00189

    IDA PAVESE, Md

    Recruiting

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

    Salerno, Salerno, 84126

    MARIA LUISA BARZELLONI, Md

    Recruiting

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

    Salerno, Salerno, 84131

    CLEMENTINA SAVASTANO, Md

    Recruiting

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

    San Giovanni Rotondo, Foggia, 71013

    EVARISTO MAIELLO, Md

    Recruiting

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

    Saronno, Varese, 21047

    CLAUDIO VERUSIO, Md

    Recruiting

  • Azienda Ospedaliera n. 1 - Annunziata Oncologia Medica

    Sassari, Sassari, 07100

    ANTONIO CONTU, Md

    Recruiting

  • Università di Sassari U.O. di Oncologia Medica

    Sassari, Sassari, 07100

    MARIA GIUSEPPA SAROBBA, Md

    Recruiting

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

    Sondalo, Sondrio, 23035

    GIUSEPPE VALMADRE, Md

    Recruiting

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

    Sondrio, Sondrio, 23100

    ALESSANDRO BERTOLINI, Md

    Recruiting

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

    Sora, Frosinone, 03039

    TERESA GAMUCCI, Md

    Recruiting

  • Ospedale Civico San Vincenzo U.O. Oncologia Medica

    Taormina, Messina, 98039

    FRANCESCO FERRAÙ, Md

    Recruiting

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

    Torino, Torino, 10125

    ANNA TURLETTI, Md

    Recruiting

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

    Torino, Torino, 10126

    Mario Airoldi, MD

    Recruiting

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

    Torino, Torino, 10126

    ANTONIO DURANDO, Md

    Recruiting

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

    Torino, Torino, 10128

    NICOLETTA BIGLIA, Md

    Recruiting

  • Azienda Ospedaliera Treviglio-Caravaggio U.O. Oncologia Medica

    Treviglio, Bergamo, 24047

    Sandro Barni, Md

    Recruiting

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

    Trieste, Trieste, 34147

    Active, not recruiting

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

    Udine, Udine, 33100

    FABIO PUGLISI, Md

    Recruiting

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

    Vallo della Lucania, Salerno, 84078

    PIETRO MASULLO, Md

    Recruiting

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

    Varese, Varese, 21100

    GRAZIELLA PINOTTI, Md

    Recruiting

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

    Viterbo, Viterbo, 01100

    LUCA MOSCETTI, Md

    Recruiting

Other trials in Italy

About this study

Official title: A Randomized Trial With Factorial Design Comparing Fulvestrant ± Lapatinib ± Aromatase Inhibitor in Metastatic Breast Cancer Progressing After Aromatase Inhibitor Therapy

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.

Read the detailed description

In presence of ER hypersensitivity even a small amount of ER may be sufficient for sustained growth signalling. On the other hand, ER disruption operated by fulvestrant is not complete, particularly in the initial phase of treatment. From phase III trials, indeed, The invertigators know that with the standard 250mg monthly dose the steady state of circulating drug is reached only after 5-6 injections. This may play a role since, as long as ER downregulation is concerned, a clear dose-response relationship has been reported. In such a situation, fulvestrant efficacy may be partial, particularly because the concomitant AI discharge yields a restoration of physiologic postmenopausal levels of circulating oestrogens. New dosing schedule are currently under investigation both to accelerate the achievement of the steady state (loading dose) and to achieve higher circulating drug levels (high dose) (86).

In this trial the investigators will be using the so-called 'loading dose'.

Further potential strategies to improve fulvestrant efficacy in this setting are:

  1. avoid the restoration of circulating oestrogens; B) interfere with molecular mechanisms that produce ER hypersensitivity by targeting the EGFR/ERBB2/ERB3 system.
  2. avoid the restoration of circulating oestrogens: this should be achieved by holding the AI treatment. Because some cases of progression upon AIs may be related to an inefficient inhibition of the aromatase it is a logical step to test whether changing AI class (from type I, steroidal, to type II, non steroidal, and vice-versa) (87), may improve fulvestrant efficay. In this view, pts in this trial will be randomized to receive fulvestrant (loading dose) with or without the alternate class AI treatment. Circulating oestrogens levels will be tracked to verify inhibition of aromatase for pts assigned to concurrent AI treatment.
  3. Interfere with growth factors-mediated ER hypersensitivity: although fulvestrant is able to overcome the ER hypersensitivity of LTED (88) and produce a growth arrest, this activity may not be complete because of incomplete ER disruption, but also because of a direct stimulation of growth by the hyperactivated EGFR/ERBB2/ERB3 system. Laboratory evidence support this hypothesis. Indeed, breast cancer cell lines exposed to long-term treatment with fulvestrant became insensitive to the drug and restore growth (89). This growth does not appear, however, related to the development of direct resistance to the drug, since ER mediated signalling continue to be efficiently suppressed in these cells; rather it may be driven by the use of alternative growth-stimulating pathway, including the EGFR system. Indeed, it can be abrogated by the EGFR-tyrosine Kinase inhibitor Gefitinib (IRESSA™) and by an MAPK-inhibitor (90). Lapatinib (GW572016) is an orally active small molecule that reversibly inhibits ErbB1 and ErbB2 tyrosine kinases, which in turn blocks phosphorylation and activation of Erk1/2 (p-Erk1/2) and Akt (p-Akt) in ErbB1- and/ or ErbB2-expressing tumor cell lines and xenografts (91-94). Lapatinib elicits cytostatic or cytotoxic antitumor effects depending on the cell type (95;96). Because ErbB2-containing heterodimers exert potent mitogenic signals, simultaneously interrupting both ErbB1 and ErbB2 signaling is an appealing therapeutic approach. Moreover, ErbB3 signaling is also involved in lapatinib action. Indeed ErbB3 is kinase-dead and relies on ErbB2 for transactivation: ErbB2-ErbB3 heterodimers are potent activators of the PI3K-Akt survival pathway (97;98), which can, in turn, inhibited by lapatinib.

Based on its molecular mechanism of action, on its fair toxicity profile and on its promising, although preliminary, activity data, Lapatinib appears an ideal candidate to combine with Fulvestrant in the attempt to improve its efficacy in patients progressing on AIs.

Being tested
Fulvestrant, Lapatinib, Aromatase Inhibitors, Placebo Lapatinib
Keywords
Fulvestrant, Lapatinib, Aromatase Inhibitor, metastatic breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FulvestrantDrug

    Also called Faslodex

    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.

  • LapatinibDrug

    1500mg (TBD) O.S. qd

  • Aromatase InhibitorsDrug

    Also called Aromatase Inhibitor

    as indicated in the Summary Product Characteristic

  • Placebo LapatinibDrug

    Also called Placebo

    1500mg (TBD) O.S. qd

Study groups in NCT02394496
Study groupRoleWhat they receive
ARM 1ExperimentalFulvestrant + Placebo Lapatinib
Receives: Drug: Fulvestrant; Drug: Placebo Lapatinib
ARM 2ExperimentalFulvestrant + Aromatase Inhibitors + Placebo Lapatinib
Receives: Drug: Fulvestrant; Drug: Aromatase Inhibitors; Drug: Placebo Lapatinib
ARM 3ExperimentalFulvestrant + Lapatinib
Receives: Drug: Fulvestrant; Drug: Lapatinib
ARM 4ExperimentalFulvestrant + Lapatinib + Aromatase Inhibitors
Receives: Drug: Fulvestrant; Drug: Lapatinib; Drug: Aromatase Inhibitors

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Time To Progression

    Time to Progression (TTP): it is defined as the time between the first study dose administration and the date of progression of the disease or cancer-related death, whichever occurs first.

    Measured: 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

  2. Overall Survival

    Overall survival. (OS): it is defined as the time between the first study dose administration and the date death from any cause.

    Measured: 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

  3. Response Rate:

    Response Rate: It will be classified according to the RECIST criteria.

    Measured: 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

  4. Clinical Benefit Rate

    Clinical Benefit Rate: it is defined as the sum of rates of PR, CR and SD lasting ≥ 6 months.

    Measured: 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

  5. Safety as measured by expected and Non-expected toxicity events

    To evaluate expected and Non-expected toxicity events that occur in more than 5% of patients in any of the study group, as reported by the CTC.

    Measured: 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

  6. Safety assessed by number of Participants with Adverse Events

    Withdrawals from the treatment plan (causes of withdrawals will be compared per each study group).

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2015 (estimated)
  2. Study startNov 2007
  3. Primary completionDec 2016 (estimated)
  4. Study completionJan 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02394496
Sponsor's protocol ID
GIM8-OVER
Other IDs
2007-006031-30
Acronym
OVER
Status last verified
Jun 2016
First submitted
16 Dec 2014
Last updated
15 Jun 2016
Results posted
No
Data monitoring committee
No

Publications

  • McPherson K, Steel CM, Dixon JM. ABC of breast diseases. Breast cancer-epidemiology, risk factors, and genetics. BMJ. 2000 Sep 9;321(7261):624-8. doi: 10.1136/bmj.321.7261.624. No abstract available.

    PubMed 10977847

  • Fisher B, Anderson S, Tan-Chiu E, Wolmark N, Wickerham DL, Fisher ER, Dimitrov NV, Atkins JN, Abramson N, Merajver S, Romond EH, Kardinal CG, Shibata HR, Margolese RG, Farrar WB. Tamoxifen and chemotherapy for axillary node-negative, estrogen receptor-negative breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-23. J Clin Oncol. 2001 Feb 15;19(4):931-42. doi: 10.1200/JCO.2001.19.4.931.

    PubMed 11181655

  • Meric F, Hung MC, Hortobagyi GN, Hunt KK. HER2/neu in the management of invasive breast cancer. J Am Coll Surg. 2002 Apr;194(4):488-501. doi: 10.1016/s1072-7515(02)01121-3. No abstract available.

    PubMed 11949754

  • Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. doi: 10.1056/NEJM200103153441101.

    PubMed 11248153

  • Nicholson RI, Gee JM, Harper ME. EGFR and cancer prognosis. Eur J Cancer. 2001 Sep;37 Suppl 4:S9-15. doi: 10.1016/s0959-8049(01)00231-3.

    PubMed 11597399

  • Yarden Y, Sliwkowski MX. Untangling the ErbB signalling network. Nat Rev Mol Cell Biol. 2001 Feb;2(2):127-37. doi: 10.1038/35052073.

    PubMed 11252954

  • Burstein HJ. The distinctive nature of HER2-positive breast cancers. N Engl J Med. 2005 Oct 20;353(16):1652-4. doi: 10.1056/NEJMp058197. No abstract available.

    PubMed 16236735

  • Lu Y, Zi X, Zhao Y, Mascarenhas D, Pollak M. Insulin-like growth factor-I receptor signaling and resistance to trastuzumab (Herceptin). J Natl Cancer Inst. 2001 Dec 19;93(24):1852-7. doi: 10.1093/jnci/93.24.1852.

    PubMed 11752009

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fulvestrant, Lapatinib and Aromatase Inhibitors in people with Metastatic Breast Cancer, run by Consorzio Oncotech at 69 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Clinical Research Technology (0039089301545), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02394496, which also lists 61 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.

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