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Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB) - ONT-380-206

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico


Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

1. Histologically confirmed HER2+ breast carcinoma, with HER2+ defined by in situ hybridization (ISH) or fluorescence in situ hybridization (FISH) methodology
2. Received previous treatment with trastuzumab, pertuzumab, and T-DM1
3. Progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy
4. Have measurable or non-measurable disease assessable by RECIST 1.1
5. At least 18 years of age at time of consent
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
7. Adequate hepatic and renal function
8. Left ventricular ejection fraction (LVEF) ≥ 50%
9. CNS Inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must have one of the following:
- No evidence of brain metastases
- Untreated brain metastases not needing immediate local therapy
- Previously treated brain metastases not needing immediate local therapy
1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy
2. Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if the following criteria are met:
i. Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days.
ii. Other sites of evaluable disease are present
iii. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions

Criteri di esclusione: 

-Previously been treated with:
1. lapatinib within 12 months of starting study treatment (except in cases where lapatinib was given for ≤ 21 days and was discontinued for reasons other than disease progression or toxicity)
2. neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) at any time previously
3. previously been treated with capecitabine for metastatic disease except in cases where capecitabine was given for < 21 days and was discontinued for reasons other than disease progression or toxicity. Patients who have received capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment are eligible.
Clinically significant cardiopulmonary disease
- Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease
- Positive for human immunodeficiency virus (HIV)
- Unable for any reason to undergo MRI of the brain
- CNS Exclusion - Based on screening brain MRI, patients must not have any of the following:
Any untreated brain lesions > 2.0 cm in size, unless discussed with medical monitor
Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent)
Any brain lesion thought to require immediate local therapy. Patients who undergo local treatment for such lesions identified by screening contrast brain MRI may still be eligible for the study based on criteria described under CNS inclusion criteria
Known or concurrent leptomeningeal disease (LMD)
Poorly controlled seizures

Schema di trattamento: 

Treatment will be administered in cycles of 21 days each. Tucatinib 300 mg or placebo will be given orally twice daily (PO BID). Capecitabine will be given at 1000 mg/m2 PO BID on Days 1–14 of each 21-day cycle. Trastuzumab will be given as a loading dose of 8 mg/kg intravenously (IV) followed by 6 mg/kg once every 21 days, except in specific circumstances where it may be given
weekly to compensate for modifications in treatment schedule.

Trattamento sperimentale: 


Trattamento di controllo: 


Obiettivi primari dello studio: 

To assess the effect of tucatinib vs. placebo in combination with capecitabine and trastuzumab on progression-free survival (PFS) per RECIST 1.1 based on independent central review

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO

Riferimento: Dr. Claudio Zamagni
Telefono: 0512144548


ASST di Cremona
Viale Concordia 1 - 26100 Cremona - CR

Riferimento: Dr. Daniele Generali


IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE

Riferimento: Dr.ssa Lucia Del Mastro


IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

Riferimento: Dr.ssa Giulia Bianchi


Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Dr. Marco Colleoni
Telefono: 0257489970


Ospedale di Carpi e Mirandola
Via G. Molinari 2 - 41012 Carpi - MO

Riferimento: Dr. Fabrizio Artioli


Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

Riferimento: Prof. Pierfranco Conte
Telefono: 0498215290

Informazioni Generali


Numero di iscrizione a registro: 2015-002801-12

Data di inserimento: 08.06.2018





Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano

Riferimento: Dr. Marco Colleoni

Telefono: 0257489970


Localita: Milano


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