Overcoming Endocrine Resistance in Metastatic Breast Cancer
NCT ID: NCT02394496
Last Updated: 2016-06-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE3
Total Enrollment
396 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-11-30
Study Completion Date
2017-01-31
Brief Summary
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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.
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Detailed Description
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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:
A) avoid the restoration of circulating oestrogens; B) interfere with molecular mechanisms that produce ER hypersensitivity by targeting the EGFR/ERBB2/ERB3 system.
A) 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.
B) 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.
In this trial the investigators will be using the so-called 'loading dose'.
Further potential strategies to improve fulvestrant efficacy in this setting are:
A) avoid the restoration of circulating oestrogens; B) interfere with molecular mechanisms that produce ER hypersensitivity by targeting the EGFR/ERBB2/ERB3 system.
A) 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.
B) 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.
Conditions
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Metastatic Breast Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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ARM 1
Fulvestrant + Placebo Lapatinib
Group Type
EXPERIMENTAL
Fulvestrant
Intervention Type
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.
Placebo Lapatinib
Intervention Type
DRUG
1500mg (TBD) O.S. qd
ARM 2
Fulvestrant + Aromatase Inhibitors + Placebo Lapatinib
Group Type
EXPERIMENTAL
Fulvestrant
Intervention Type
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.
Aromatase Inhibitors
Intervention Type
DRUG
as indicated in the Summary Product Characteristic
Placebo Lapatinib
Intervention Type
DRUG
1500mg (TBD) O.S. qd
ARM 3
Fulvestrant + Lapatinib
Group Type
EXPERIMENTAL
Fulvestrant
Intervention Type
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.
Lapatinib
Intervention Type
DRUG
1500mg (TBD) O.S. qd
ARM 4
Fulvestrant + Lapatinib + Aromatase Inhibitors
Group Type
EXPERIMENTAL
Fulvestrant
Intervention Type
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.
Lapatinib
Intervention Type
DRUG
1500mg (TBD) O.S. qd
Aromatase Inhibitors
Intervention Type
DRUG
as indicated in the Summary Product Characteristic
Interventions
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Fulvestrant
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.
Intervention Type
DRUG
Lapatinib
1500mg (TBD) O.S. qd
Intervention Type
DRUG
Aromatase Inhibitors
as indicated in the Summary Product Characteristic
Intervention Type
DRUG
Placebo Lapatinib
1500mg (TBD) O.S. qd
Intervention Type
DRUG
Other Intervention Names
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Faslodex
Aromatase Inhibitor
Placebo
Eligibility Criteria
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Inclusion Criteria
1. Provision of written informed consent
2. Histological/cytological confirmation of breast cancer
3. Documented positive hormone receptor status (ER+ve and/or PgR+ve) of primary or metastaic tumor issue, according to the local laboratory parameters
4. Postmenopausal women
5. Confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors
6. Patients demonstrating prior response to AI therapy
7. 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.
8. May have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry;
9. Life expectancy of at least 8 months
10. WHO performance status 0, 1 or 2
11. 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.
12. Are able to swallow and retain oral medication;
13. Are able to complete all screening assessments as outlined in the protocol;
14. Patients must have normal organ and marrow function
15. Left ventricular ejection fraction (LVEF) within the institutional normal range
2. Histological/cytological confirmation of breast cancer
3. Documented positive hormone receptor status (ER+ve and/or PgR+ve) of primary or metastaic tumor issue, according to the local laboratory parameters
4. Postmenopausal women
5. Confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors
6. Patients demonstrating prior response to AI therapy
7. 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.
8. May have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry;
9. Life expectancy of at least 8 months
10. WHO performance status 0, 1 or 2
11. 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.
12. Are able to swallow and retain oral medication;
13. Are able to complete all screening assessments as outlined in the protocol;
14. Patients must have normal organ and marrow function
15. Left ventricular ejection fraction (LVEF) within the institutional normal range
Exclusion Criteria
1. Previous therapy with Fulvestrant and/or Lapatinib;
2. Patients with HER 2 overexpressing, either IHC 3+ or FISH +;
3. Concurrent non study anti-cancer therapy (
4. Have unresolved or unstable, serious toxicity from prior administration
5. Have malabsorption syndrome,
6. Have a concurrent disease or condition that would make the patient inappropriate for study participation,
7. Have an active or uncontrolled infection;
8. Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
9. Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;
10. Receive concurrent treatment with an investigational agent or participate in another clinical trial;
11. Receive concurrent treatment with prohibited medications
12. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
13. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.
2. Patients with HER 2 overexpressing, either IHC 3+ or FISH +;
3. Concurrent non study anti-cancer therapy (
4. Have unresolved or unstable, serious toxicity from prior administration
5. Have malabsorption syndrome,
6. Have a concurrent disease or condition that would make the patient inappropriate for study participation,
7. Have an active or uncontrolled infection;
8. Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
9. Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;
10. Receive concurrent treatment with an investigational agent or participate in another clinical trial;
11. Receive concurrent treatment with prohibited medications
12. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
13. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Consorzio Oncotech
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Sabino De Placido, MD
Role: PRINCIPAL_INVESTIGATOR
Dipartimento di Medicina Clinica e Chirurgia Oncologia Università degli Studi di Napoli "Federico II"
Michelino De Laurentiis, MD
Role: STUDY_CHAIR
Istituto Nazionale dei Tumori - Fondazione G. Pascale
Locations
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A.S.U.R. Zona Territoriale 6 Fabriano U.O. Oncologia Medica
Fabriano, Ancona, Italy
Site Status
RECRUITING
Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico U.O. Oncologia Medica e Sperimentale
Bari, Bari, Italy
Site Status
RECRUITING
Azienda Ospedaliera G. Rummo U.O. di Oncologia Medica
Benevento, Benevento, Italy
Site Status
RECRUITING
Ospedale Fatebenefratelli 'Sacro Cuore di Gesù' U.O. Oncologia
Benevento, Benevento, Italy
Site Status
RECRUITING
Azienda Ospedaliera Treviglio-Caravaggio U.O. Oncologia Medica
Treviglio, Bergamo, Italy
Site Status
RECRUITING
Presidio Ospedaliero 'Antonio Perrino' U.O.C. di Oncologia
Brindisi, Brindisi, Italy
Site Status
RECRUITING
dazione di Ricerca e Cura 'Giovanni Paolo II' U.O. di Ginecologia Oncologia
Campobasso, Campobasso, Italy
Site Status
RECRUITING
Ospedale Civile di Campobasso - A. Cardarelli U.O.C. Oncologia Medica
Campobasso, Campobasso, Italy
Site Status
RECRUITING
Azienda Ospedaliera 'Sant'Anna e San Sebastiano' U.O.C. di Oncologia
Caserta, Caserta, Italy
Site Status
RECRUITING
Presidio Ospedaliero Garibaldi - Nesima S.C. di Oncologia Medica
Catania, Catania, Italy
Site Status
RECRUITING
A.O.U. Ospedale Vittorio Emanuele e Ferrarotto U.O. di Oncologia Medica
Catania, Catania, Italy
Site Status
RECRUITING
Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica
Catania, Catania, Italy
Site Status
RECRUITING
Ospedale Civile Renzetti U.O. Oncologia Medica
Lanciano, Chieti, Italy
Site Status
RECRUITING
Azienda Ospedaliera S. Anna U.O. di Oncologia Medica
Como, Como, Italy
Site Status
RECRUITING
Ospedale S. Francesco da Paola U.O. Oncologia Medica
Paola, Cosenza, Italy
Site Status
ACTIVE_NOT_RECRUITING
Arcispedaliera S. Anna di Ferrara U.O. Oncologia Clinica
Ferrara, Ferrara, Italy
Site Status
RECRUITING
IRCCS - 'Casa Sollievo della Sofferenza' U.O. Oncologia Medica
San Giovanni Rotondo, Foggia, Italy
Site Status
RECRUITING
Ospedale 'SS. Trinità' U.O. Oncologia Medica
Sora, Frosinone, Italy
Site Status
RECRUITING
I.R.C.C.S. A.O.U. San Martino - I.S.T. S.C. Oncologia Medica A
Genova, Genova, Italy
Site Status
RECRUITING
ASRM - Ospedale F. Veneziale - Zona di Isernia U.O. Oncologia
Isernia, Isernia, Italy
Site Status
RECRUITING
A.S.L. LT - Ospedale Santa Maria Goretti U.O.C. di Oncologia Medica
Latina, Latina, Italy
Site Status
RECRUITING
Ospedale Vito Fazzi U.O. di Oncologia
Lecce, Lecce, Italy
Site Status
RECRUITING
Ospedale Unico Versilia U.O. Oncologia Medica
Lido di Camaiore, Lucca, Italy
Site Status
RECRUITING
Ospedale Civico San Vincenzo U.O. Oncologia Medica
Taormina, Messina, Italy
Site Status
RECRUITING
Istituto Europeo di Oncologia (IRCCS) Dipartimento di Medicina - Unità Cure Mediche
Milan, Milano, Italy
Site Status
RECRUITING
Azienda Ospedaliera Cardarelli Divisione Di Oncologia
Napoli, Napoli, Italy
Site Status
RECRUITING
Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica
Napoli, Napoli, Italy
Site Status
RECRUITING
Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia
Napoli, Napoli, Italy
Site Status
RECRUITING
A.O.U. 'Maggiore della Carità' S.C. Oncologia
Novara, Novara, Italy
Site Status
RECRUITING
Istituto Oncologico Veneto - I.R.C.C.S. U.O. di Oncologia Medica II
Padua, Padova, Italy
Site Status
RECRUITING
A.O.U.P. 'Paolo Giaccone' U.O.C. di Oncologia Medica
Palermo, Palermo, Italy
Site Status
RECRUITING
A.R.N.A.S - Ospedale Civico e Benfratelli G. Di Cristina e M. Ascoli Divisione di Oncologia Medica
Palermo, Palermo, Italy
Site Status
RECRUITING
Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II
Pavia, Pavia, Italy
Site Status
RECRUITING
IRCCS Policlinico S. Matteo S.C. di Oncologia Medica
Pavia, Pavia, Italy
Site Status
ACTIVE_NOT_RECRUITING
Ospedale S. Maria della Misericordia S.C. Oncologia Medica
Perugia, Perugia, Italy
Site Status
RECRUITING
AUSL di Piacenza - Ospedale U.O. Oncologia Medica
Piacenza, Piacenza, Italy
Site Status
RECRUITING
Ospedale 'Felice Lotti' - Azienda USL 5 di Pisa U.O. di Oncologia Medica
Pontedera, Pisa, Italy
Site Status
RECRUITING
Centro di Riferimento Oncologico S.O.C. di Oncologia Medica C
Aviano, Pordenone, Italy
Site Status
RECRUITING
Azienda Ospedaliera Santa Maria degli Angeli U.O. Oncolgia Medica
Pordenone, Pordenone, Italy
Site Status
RECRUITING
Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata U.O. di Oncologia Medica
Rionero in Vulture, Potenza, Italy
Site Status
RECRUITING
Azienda Ospedaliera Bianchi - Melacrino - Morelli U.O. di Oncologia Medica
Reggio Calabria, Reggio Calabria, Italy
Site Status
RECRUITING
Ospedale San Sebastiano Day Hospital Oncologico - Divisione Medicina Acuti
Correggio, Reggio Emilia, Italy
Site Status
RECRUITING
Arcispedale S.Maria Nuova Servizio di Oncologia
Reggio Emilia, Reggio Emilia, Italy
Site Status
RECRUITING
Istituto Regina Elena per lo studio e la cura dei tumori S.C. Oncologia Medica A
Roma, Roma, Italy
Site Status
RECRUITING
Azienda Ospedaliera San Camillo - Forlanini Day Hospital Oncologia Mammella
Roma, Roma, Italy
Site Status
RECRUITING
Policlinico Universitario 'Agostino Gemelli' U.O.C. Ginecologia Oncologica
Roma, Roma, Italy
Site Status
RECRUITING
Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina U.O. Oncologia
Roma, Roma, Italy
Site Status
RECRUITING
Azienda Ospedaliera S. Andrea - Università La Sapienza U.O.C. Oncologia
Roma, Roma, Italy
Site Status
RECRUITING
Ospedale San Pietro Fatebenefratelli Dipartimento di Oncologia - Day Hospital Oncologico
Roma, Roma, Italy
Site Status
RECRUITING
Azienda Ospedaliera - Ospedale Umberto I U.O. di Medicina e Oncoematologia
Nocera Inferiore, Salerno, Italy
Site Status
RECRUITING
Ospedale G. Da Procida - ASL SA U.O. di Oncologia
Salerno, Salerno, Italy
Site Status
RECRUITING
Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia
Salerno, Salerno, Italy
Site Status
RECRUITING
Presidio Ospedaliero di Vallo della Lucania U.O. Oncologia Medica
Vallo della Lucania, Salerno, Italy
Site Status
RECRUITING
Azienda Ospedaliera n. 1 - Annunziata Oncologia Medica
Sassari, Sassari, Italy
Site Status
RECRUITING
Università di Sassari U.O. di Oncologia Medica
Sassari, Sassari, Italy
Site Status
RECRUITING
AOVV - Ospedale E. Morelli S.O.C. Medicina Interna - D.H. Oncologico-Ematologico-Internistico
Sondalo, Sondrio, Italy
Site Status
RECRUITING
Ospedale Civile di Sondrio - Azienda Ospedaliera Valtellina e Valchiavenna S.C. Oncologia Medica
Sondrio, Sondrio, Italy
Site Status
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, Italy
Site Status
RECRUITING
Ospedale Evangelico Valdese - ASL TO1 U.O. di Oncologia Medica
Torino, Torino, Italy
Site Status
RECRUITING
Presidio San Lazzaro - A.O.U. San Giovanni Battista di Torino (Molinette) S.C. Oncologia Medica II
Torino, Torino, Italy
Site Status
RECRUITING
Università degli Studi di Torino - Ospedale S. Anna U.O. di Oncologia Medica
Torino, Torino, Italy
Site Status
RECRUITING
Ospedale Mauriziano Umberto I S.C.D.U. Ginecologia e Ostetricia
Torino, Torino, Italy
Site Status
RECRUITING
Centro Oncologico A.S.S. N°1 Triestina Centro Sociale Oncologico
Trieste, Trieste, Italy
Site Status
ACTIVE_NOT_RECRUITING
A.O.U. ´S. Maria della Misericordia´ Dipartimento di Oncologia
Udine, Udine, Italy
Site Status
RECRUITING
Ospedale 'S. Antonio Abate' U.O. Oncologia
Gallarate, Varese, Italy
Site Status
ACTIVE_NOT_RECRUITING
Azienda Ospedaliera Busto Arsizio - Presidio Ospedaliero Saronno S.C. Oncologia Medica
Saronno, Varese, Italy
Site Status
RECRUITING
Azienda Ospedaliera Circolo e Fondazione Macchi U.O. di Oncologia Medica
Varese, Varese, Italy
Site Status
RECRUITING
Ospedale Sacro Cuore - Don Calabria U.O.C. Oncologia Medica
Negrar, Verona, Italy
Site Status
RECRUITING
Presidio Ospedaliero 'Belcolle' U.O.C. Oncologia Medica
Viterbo, Viterbo, Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Clinical Research Technology
Role: CONTACT
0039089301545
Facility Contacts
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Massimo Aglietta, MD
Role: primary
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Yarden Y, Sliwkowski MX. Untangling the ErbB signalling network. Nat Rev Mol Cell Biol. 2001 Feb;2(2):127-37. doi: 10.1038/35052073.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Xia W, Liu LH, Ho P, Spector NL. Truncated ErbB2 receptor (p95ErbB2) is regulated by heregulin through heterodimer formation with ErbB3 yet remains sensitive to the dual EGFR/ErbB2 kinase inhibitor GW572016. Oncogene. 2004 Jan 22;23(3):646-53. doi: 10.1038/sj.onc.1207166.
Reference Type
BACKGROUND
Gerber HP, Malik AK, Solar GP, Sherman D, Liang XH, Meng G, Hong K, Marsters JC, Ferrara N. VEGF regulates haematopoietic stem cell survival by an internal autocrine loop mechanism. Nature. 2002 Jun 27;417(6892):954-8. doi: 10.1038/nature00821.
Reference Type
BACKGROUND
Albanell J, Codony-Servat J, Rojo F, Del Campo JM, Sauleda S, Anido J, Raspall G, Giralt J, Rosello J, Nicholson RI, Mendelsohn J, Baselga J. Activated extracellular signal-regulated kinases: association with epidermal growth factor receptor/transforming growth factor alpha expression in head and neck squamous carcinoma and inhibition by anti-epidermal growth factor receptor treatments. Cancer Res. 2001 Sep 1;61(17):6500-10.
Reference Type
BACKGROUND
Rubin Grandis J, Melhem MF, Gooding WE, Day R, Holst VA, Wagener MM, Drenning SD, Tweardy DJ. Levels of TGF-alpha and EGFR protein in head and neck squamous cell carcinoma and patient survival. J Natl Cancer Inst. 1998 Jun 3;90(11):824-32. doi: 10.1093/jnci/90.11.824.
Reference Type
BACKGROUND
Howell GM, Humphrey LE, Awwad RA, Wang D, Koterba A, Periyasamy B, Yang J, Li W, Willson JK, Ziober BL, Coleman K, Carboni J, Lynch M, Brattain MG. Aberrant regulation of transforming growth factor-alpha during the establishment of growth arrest and quiescence of growth factor independent cells. J Biol Chem. 1998 Apr 10;273(15):9214-23. doi: 10.1074/jbc.273.15.9214.
Reference Type
BACKGROUND
Jiang D, Yang H, Willson JK, Liang J, Humphrey LE, Zborowska E, Wang D, Foster J, Fan R, Brattain MG. Autocrine transforming growth factor alpha provides a growth advantage to malignant cells by facilitating re-entry into the cell cycle from suboptimal growth states. J Biol Chem. 1998 Nov 20;273(47):31471-9. doi: 10.1074/jbc.273.47.31471.
Reference Type
BACKGROUND
Rusnak DW, Affleck K, Cockerill SG, Stubberfield C, Harris R, Page M, Smith KJ, Guntrip SB, Carter MC, Shaw RJ, Jowett A, Stables J, Topley P, Wood ER, Brignola PS, Kadwell SH, Reep BR, Mullin RJ, Alligood KJ, Keith BR, Crosby RM, Murray DM, Knight WB, Gilmer TM, Lackey K. The characterization of novel, dual ErbB-2/EGFR, tyrosine kinase inhibitors: potential therapy for cancer. Cancer Res. 2001 Oct 1;61(19):7196-203.
Reference Type
BACKGROUND
Vogel CL, Cobleigh MA, Tripathy D, Gutheil JC, Harris LN, Fehrenbacher L, Slamon DJ, Murphy M, Novotny WF, Burchmore M, Shak S, Stewart SJ, Press M. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol. 2002 Feb 1;20(3):719-26. doi: 10.1200/JCO.2002.20.3.719.
Reference Type
BACKGROUND
Grossi PM, Ochiai H, Archer GE, McLendon RE, Zalutsky MR, Friedman AH, Friedman HS, Bigner DD, Sampson JH. Efficacy of intracerebral microinfusion of trastuzumab in an athymic rat model of intracerebral metastatic breast cancer. Clin Cancer Res. 2003 Nov 15;9(15):5514-20.
Reference Type
BACKGROUND
Pestalozzi BC, Brignoli S. Trastuzumab in CSF. J Clin Oncol. 2000 Jun;18(11):2349-51. doi: 10.1200/JCO.2000.18.11.2349. No abstract available.
Reference Type
BACKGROUND
Cobleigh MA, Vogel CL, Tripathy D, Robert NJ, Scholl S, Fehrenbacher L, Wolter JM, Paton V, Shak S, Lieberman G, Slamon DJ. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol. 1999 Sep;17(9):2639-48. doi: 10.1200/JCO.1999.17.9.2639.
Reference Type
BACKGROUND
Burstein HJ, Kuter I, Campos SM, Gelman RS, Tribou L, Parker LM, Manola J, Younger J, Matulonis U, Bunnell CA, Partridge AH, Richardson PG, Clarke K, Shulman LN, Winer EP. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. J Clin Oncol. 2001 May 15;19(10):2722-30. doi: 10.1200/JCO.2001.19.10.2722.
Reference Type
BACKGROUND
Bendell JC, Domchek SM, Burstein HJ, Harris L, Younger J, Kuter I, Bunnell C, Rue M, Gelman R, Winer E. Central nervous system metastases in women who receive trastuzumab-based therapy for metastatic breast carcinoma. Cancer. 2003 Jun 15;97(12):2972-7. doi: 10.1002/cncr.11436.
Reference Type
BACKGROUND
Clayton AJ, Danson S, Jolly S, Ryder WD, Burt PA, Stewart AL, Wilkinson PM, Welch RS, Magee B, Wilson G, Howell A, Wardley AM. Incidence of cerebral metastases in patients treated with trastuzumab for metastatic breast cancer. Br J Cancer. 2004 Aug 16;91(4):639-43. doi: 10.1038/sj.bjc.6601970.
Reference Type
BACKGROUND
Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, Vogel V, Robidoux A, Dimitrov N, Atkins J, Daly M, Wieand S, Tan-Chiu E, Ford L, Wolmark N. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998 Sep 16;90(18):1371-88. doi: 10.1093/jnci/90.18.1371.
Reference Type
BACKGROUND
Encarnacion CA, Ciocca DR, McGuire WL, Clark GM, Fuqua SA, Osborne CK. Measurement of steroid hormone receptors in breast cancer patients on tamoxifen. Breast Cancer Res Treat. 1993;26(3):237-46. doi: 10.1007/BF00665801.
Reference Type
BACKGROUND
Hull DF 3rd, Clark GM, Osborne CK, Chamness GC, Knight WA 3rd, McGuire WL. Multiple estrogen receptor assays in human breast cancer. Cancer Res. 1983 Jan;43(1):413-6.
Reference Type
BACKGROUND
Buzdar AU, Jonat W, Howell A, Jones SE, Blomqvist CP, Vogel CL, Eiermann W, Wolter JM, Steinberg M, Webster A, Lee D. Anastrozole versus megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma: results of a survival update based on a combined analysis of data from two mature phase III trials. Arimidex Study Group. Cancer. 1998 Sep 15;83(6):1142-52.
Reference Type
BACKGROUND
Buzdar A, Douma J, Davidson N, Elledge R, Morgan M, Smith R, Porter L, Nabholtz J, Xiang X, Brady C. Phase III, multicenter, double-blind, randomized study of letrozole, an aromatase inhibitor, for advanced breast cancer versus megestrol acetate. J Clin Oncol. 2001 Jul 15;19(14):3357-66. doi: 10.1200/JCO.2001.19.14.3357.
Reference Type
BACKGROUND
Dombernowsky P, Smith I, Falkson G, Leonard R, Panasci L, Bellmunt J, Bezwoda W, Gardin G, Gudgeon A, Morgan M, Fornasiero A, Hoffmann W, Michel J, Hatschek T, Tjabbes T, Chaudri HA, Hornberger U, Trunet PF. Letrozole, a new oral aromatase inhibitor for advanced breast cancer: double-blind randomized trial showing a dose effect and improved efficacy and tolerability compared with megestrol acetate. J Clin Oncol. 1998 Feb;16(2):453-61. doi: 10.1200/JCO.1998.16.2.453.
Reference Type
BACKGROUND
Bonneterre J, Buzdar A, Nabholtz JM, Robertson JF, Thurlimann B, von Euler M, Sahmoud T, Webster A, Steinberg M; Arimidex Writing Committee; Investigators Committee Members. Anastrozole is superior to tamoxifen as first-line therapy in hormone receptor positive advanced breast carcinoma. Cancer. 2001 Nov 1;92(9):2247-58. doi: 10.1002/1097-0142(20011101)92:93.0.co;2-y.
Reference Type
BACKGROUND
Mouridsen H, Gershanovich M, Sun Y, Perez-Carrion R, Boni C, Monnier A, Apffelstaedt J, Smith R, Sleeboom HP, Janicke F, Pluzanska A, Dank M, Becquart D, Bapsy PP, Salminen E, Snyder R, Lassus M, Verbeek JA, Staffler B, Chaudri-Ross HA, Dugan M. Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International Letrozole Breast Cancer Group. J Clin Oncol. 2001 May 15;19(10):2596-606. doi: 10.1200/JCO.2001.19.10.2596.
Reference Type
BACKGROUND
Howell A, Robertson JF, Quaresma Albano J, Aschermannova A, Mauriac L, Kleeberg UR, Vergote I, Erikstein B, Webster A, Morris C. Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol. 2002 Aug 15;20(16):3396-403. doi: 10.1200/JCO.2002.10.057.
Reference Type
BACKGROUND
Osborne CK, Pippen J, Jones SE, Parker LM, Ellis M, Come S, Gertler SZ, May JT, Burton G, Dimery I, Webster A, Morris C, Elledge R, Buzdar A. Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J Clin Oncol. 2002 Aug 15;20(16):3386-95. doi: 10.1200/JCO.2002.10.058.
Reference Type
BACKGROUND
Howell A, Osborne CK, Morris C, Wakeling AE. ICI 182,780 (Faslodex): development of a novel, "pure" antiestrogen. Cancer. 2000 Aug 15;89(4):817-25. doi: 10.1002/1097-0142(20000815)89:43.0.co;2-6.
Reference Type
BACKGROUND
Robertson JF, Nicholson RI, Bundred NJ, Anderson E, Rayter Z, Dowsett M, Fox JN, Gee JM, Webster A, Wakeling AE, Morris C, Dixon M. Comparison of the short-term biological effects of 7alpha-[9-(4,4,5,5,5-pentafluoropentylsulfinyl)-nonyl]estra-1,3,5, (10)-triene-3,17beta-diol (Faslodex) versus tamoxifen in postmenopausal women with primary breast cancer. Cancer Res. 2001 Sep 15;61(18):6739-46.
Reference Type
BACKGROUND
Wakeling AE, Dukes M, Bowler J. A potent specific pure antiestrogen with clinical potential. Cancer Res. 1991 Aug 1;51(15):3867-73.
Reference Type
BACKGROUND
Mauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK. Fulvestrant (Faslodex) versus anastrozole for the second-line treatment of advanced breast cancer in subgroups of postmenopausal women with visceral and non-visceral metastases: combined results from two multicentre trials. Eur J Cancer. 2003 Jun;39(9):1228-33. doi: 10.1016/s0959-8049(03)00199-0.
Reference Type
BACKGROUND
Addo S, Yates RA, Laight A. A phase I trial to assess the pharmacology of the new oestrogen receptor antagonist fulvestrant on the endometrium in healthy postmenopausal volunteers. Br J Cancer. 2002 Dec 2;87(12):1354-9. doi: 10.1038/sj.bjc.6600644.
Reference Type
BACKGROUND
DeFriend DJ, Anderson E, Bell J, Wilks DP, West CM, Mansel RE, Howell A. Effects of 4-hydroxytamoxifen and a novel pure antioestrogen (ICI 182780) on the clonogenic growth of human breast cancer cells in vitro. Br J Cancer. 1994 Aug;70(2):204-11. doi: 10.1038/bjc.1994.281.
Reference Type
BACKGROUND
Brueggemeier RW, Hackett JC, Diaz-Cruz ES. Aromatase inhibitors in the treatment of breast cancer. Endocr Rev. 2005 May;26(3):331-45. doi: 10.1210/er.2004-0015. Epub 2005 Apr 6.
Reference Type
BACKGROUND
Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003 Nov 6;349(19):1793-802. doi: 10.1056/NEJMoa032312. Epub 2003 Oct 9.
Reference Type
BACKGROUND
Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, Jones SE, Alvarez I, Bertelli G, Ortmann O, Coates AS, Bajetta E, Dodwell D, Coleman RE, Fallowfield LJ, Mickiewicz E, Andersen J, Lonning PE, Cocconi G, Stewart A, Stuart N, Snowdon CF, Carpentieri M, Massimini G, Bliss JM, van de Velde C; Intergroup Exemestane Study. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004 Mar 11;350(11):1081-92. doi: 10.1056/NEJMoa040331.
Reference Type
BACKGROUND
Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, Hoctin-Boes G, Houghton J, Locker GY, Tobias JS; ATAC Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet. 2005 Jan 1-7;365(9453):60-2. doi: 10.1016/S0140-6736(04)17666-6.
Reference Type
BACKGROUND
Kao YC, Cam LL, Laughton CA, Zhou D, Chen S. Binding characteristics of seven inhibitors of human aromatase: a site-directed mutagenesis study. Cancer Res. 1996 Aug 1;56(15):3451-60.
Reference Type
BACKGROUND
Johnston SR, Dowsett M. Aromatase inhibitors for breast cancer: lessons from the laboratory. Nat Rev Cancer. 2003 Nov;3(11):821-31. doi: 10.1038/nrc1211. No abstract available.
Reference Type
BACKGROUND
Sourdaine P, Parker MG, Telford J, Miller WR. Analysis of the aromatase cytochrome P450 gene in human breast cancers. J Mol Endocrinol. 1994 Dec;13(3):331-7. doi: 10.1677/jme.0.0130331.
Reference Type
BACKGROUND
Miller WR. Biological rationale for endocrine therapy in breast cancer. Best Pract Res Clin Endocrinol Metab. 2004 Mar;18(1):1-32. doi: 10.1016/s1521-690x(03)00044-7.
Reference Type
BACKGROUND
Jeng MH, Shupnik MA, Bender TP, Westin EH, Bandyopadhyay D, Kumar R, Masamura S, Santen RJ. Estrogen receptor expression and function in long-term estrogen-deprived human breast cancer cells. Endocrinology. 1998 Oct;139(10):4164-74. doi: 10.1210/endo.139.10.6229.
Reference Type
BACKGROUND
Shim WS, Conaway M, Masamura S, Yue W, Wang JP, Kmar R, Santen RJ. Estradiol hypersensitivity and mitogen-activated protein kinase expression in long-term estrogen deprived human breast cancer cells in vivo. Endocrinology. 2000 Jan;141(1):396-405. doi: 10.1210/endo.141.1.7270.
Reference Type
BACKGROUND
Chan CM, Martin LA, Johnston SR, Ali S, Dowsett M. Molecular changes associated with the acquisition of oestrogen hypersensitivity in MCF-7 breast cancer cells on long-term oestrogen deprivation. J Steroid Biochem Mol Biol. 2002 Aug;81(4-5):333-41. doi: 10.1016/s0960-0760(02)00074-2.
Reference Type
BACKGROUND
Martin LA, Farmer I, Johnston SR, Ali S, Marshall C, Dowsett M. Enhanced estrogen receptor (ER) alpha, ERBB2, and MAPK signal transduction pathways operate during the adaptation of MCF-7 cells to long term estrogen deprivation. J Biol Chem. 2003 Aug 15;278(33):30458-68. doi: 10.1074/jbc.M305226200. Epub 2003 May 29.
Reference Type
BACKGROUND
Santen RJ, Song RX, Zhang Z, Kumar R, Jeng MH, Masamura S, Lawrence J Jr, MacMahon LP, Yue W, Berstein L. Adaptive hypersensitivity to estrogen: mechanisms and clinical relevance to aromatase inhibitor therapy in breast cancer treatment. J Steroid Biochem Mol Biol. 2005 May;95(1-5):155-65. doi: 10.1016/j.jsbmb.2005.04.025.
Reference Type
BACKGROUND
Borras M, Laios I, el Khissiin A, Seo HS, Lempereur F, Legros N, Leclercq G. Estrogenic and antiestrogenic regulation of the half-life of covalently labeled estrogen receptor in MCF-7 breast cancer cells. J Steroid Biochem Mol Biol. 1996 Feb;57(3-4):203-13. doi: 10.1016/0960-0760(95)00272-3.
Reference Type
BACKGROUND
Dauvois S, White R, Parker MG. The antiestrogen ICI 182780 disrupts estrogen receptor nucleocytoplasmic shuttling. J Cell Sci. 1993 Dec;106 ( Pt 4):1377-88. doi: 10.1242/jcs.106.4.1377.
Reference Type
BACKGROUND
Ingle JN, Suman VJ, Rowland KM, Mirchandani D, Bernath AM, Camoriano JK, Fishkin PA, Nikcevich DA, Perez EA; North Central Cancer Treatment Group Trial N0032. Fulvestrant in women with advanced breast cancer after progression on prior aromatase inhibitor therapy: North Central Cancer Treatment Group Trial N0032. J Clin Oncol. 2006 Mar 1;24(7):1052-6. doi: 10.1200/JCO.2005.04.1053.
Reference Type
BACKGROUND
Perey L, Paridaens R, Hawle H, Zaman K, Nole F, Wildiers H, Fiche M, Dietrich D, Clement P, Koberle D, Goldhirsch A, Thurlimann B. Clinical benefit of fulvestrant in postmenopausal women with advanced breast cancer and primary or acquired resistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical Cancer Research Trial (SAKK 21/00). Ann Oncol. 2007 Jan;18(1):64-69. doi: 10.1093/annonc/mdl341. Epub 2006 Oct 9.
Reference Type
BACKGROUND
Gradishar WJ, Sahmoud T. Current and future perspectives on fulvestrant. Clin Breast Cancer. 2005 Apr;6 Suppl 1:S23-9. doi: 10.3816/cbc.2005.s.011.
Reference Type
BACKGROUND
McClelland RA, Barrow D, Madden TA, Dutkowski CM, Pamment J, Knowlden JM, Gee JM, Nicholson RI. Enhanced epidermal growth factor receptor signaling in MCF7 breast cancer cells after long-term culture in the presence of the pure antiestrogen ICI 182,780 (Faslodex). Endocrinology. 2001 Jul;142(7):2776-88. doi: 10.1210/endo.142.7.8259.
Reference Type
BACKGROUND
Cockerill S, Stubberfield C, Stables J, Carter M, Guntrip S, Smith K, McKeown S, Shaw R, Topley P, Thomsen L, Affleck K, Jowett A, Hayes D, Willson M, Woollard P, Spalding D. Indazolylamino quinazolines and pyridopyrimidines as inhibitors of the EGFr and C-erbB-2. Bioorg Med Chem Lett. 2001 Jun 4;11(11):1401-5. doi: 10.1016/s0960-894x(01)00219-0.
Reference Type
BACKGROUND
Xia W, Mullin RJ, Keith BR, Liu LH, Ma H, Rusnak DW, Owens G, Alligood KJ, Spector NL. Anti-tumor activity of GW572016: a dual tyrosine kinase inhibitor blocks EGF activation of EGFR/erbB2 and downstream Erk1/2 and AKT pathways. Oncogene. 2002 Sep 12;21(41):6255-63. doi: 10.1038/sj.onc.1205794.
Reference Type
BACKGROUND
Rusnak DW, Lackey K, Affleck K, Wood ER, Alligood KJ, Rhodes N, Keith BR, Murray DM, Knight WB, Mullin RJ, Gilmer TM. The effects of the novel, reversible epidermal growth factor receptor/ErbB-2 tyrosine kinase inhibitor, GW2016, on the growth of human normal and tumor-derived cell lines in vitro and in vivo. Mol Cancer Ther. 2001 Dec;1(2):85-94.
Reference Type
BACKGROUND
Holbro T, Beerli RR, Maurer F, Koziczak M, Barbas CF 3rd, Hynes NE. The ErbB2/ErbB3 heterodimer functions as an oncogenic unit: ErbB2 requires ErbB3 to drive breast tumor cell proliferation. Proc Natl Acad Sci U S A. 2003 Jul 22;100(15):8933-8. doi: 10.1073/pnas.1537685100. Epub 2003 Jul 9.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-006031-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GIM8-OVER
Identifier Type: -
Identifier Source: org_study_id
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