GIM27-THERapy: a Study to Describe the Effectiveness of Tucatinib in Combination With Capecitabine and Trastuzumab in the Treatment of Metastatic HER-2 Positive Breast Cancer Patients in Real World Setting

NCT07583485 | Recruiting

• 2 other identifiers: GIM27-THERapy701
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 30

Brief Summary

Non-interventional, multicenter, prospective observational study of tucatinib-trastuzumab capecitabine administered according to the standard local clinical practice following approved SmPC indication and dose. About 300 Her2 positive metastatic breast cancer patients who are candidate to tucatinib treatment in real world setting including patients previously treated with trastuzumab, pertuzumab, T-DM1, T-DXd as per authorized therapy setting and NPP/EAP ongoing program. Primary Objective: To assess the treatment safety and effectiveness as measured by investigator criteria in metastatic breast cancer patients within the real-world setting treated with tucatinib in combination with trastuzumab and capecitabine according to standard local clinical practice following approved Summary of Product Characteristics (SmPC) indication and dose. The primary purpose of this study is to evaluate the real word effectiveness of the combination therapy "tucatinib/trastuzumab/capecitabine" in mBC patients according to the approved SmPC indication and dose in the real-world setting. Patients with human epidermal growth factor receptor 2 (HER2)- positive metastatic breast cancer who have disease progression after therapy with multiple HER2-targeted agents have limited treatment options. HER2 is a transmembrane tyrosine kinase receptor that mediates cell growth, differentiation, and survival. HER2 is overexpressed in approximately 20% of breast cancers. Both antibody and small-molecule drugs that target HER2 and block its tyrosine kinase activity has been demonstrated to be effective in treating HER2-driven cancers. Tucatinib is an investigational, oral, highly selective inhibitor of the HER2 tyrosine kinase. On April 17, 2020, the Food and Drug Administration approved tucatinib in combination with trastuzumab and capecitabine, for adult patients with advanced unresectable or metastatic HER2- positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. On 10 December 2020, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for Tukysa (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer (BC) who have received at least two prior anti-HER2 treatment regimens. Tucatinib received a marketing authorization valid throughout the EU on February 2021. The approvals were based on the results of the phase II HER2CLIMB trial in which HER2-positive breast cancer patients, previously treated with trastuzumab, pertuzumab (Perjeta) and trastuzumab emtansine (T-DM1; Kadcyla), have been randomized to receive trastuzumab and capecitabine with either tucatinib or placebo (randomization 2:1).Among the 511 patients with measurable disease at baseline, an objective response was confirmed in 40.6% of patients in the tucatinib-combination group and 22.8% of patients in the placebo-combination group. The primary endpoint of the trial was PFS and the secondary end points comprised overall survival (OS), as well as confirmed objective response rate (ORR). Tucatinib demonstrated efficacy compared with placebo in PFS (7.8 months versus 5.6months) and OS (21.9 months versus 17.4 months). The most common adverse events in the tucatinib arm were diarrhea, palmar-plantar erythrodysesthesia syndrome, fatigue, nausea, and vomiting and transaminitis, even though typically low-grade, transient, and reversible. In addition, out of the ∼600 patients enrolled, 291 patients had brain metastases at baseline. Brain mets including those with active brain mets. Among patients with brain mets PFS at 1 y was 24,9% in the tucatinib combination group vs 0% in the placebo combination group, HR: 0.48;95% CI to 69%;p\<0.0001 and median PFS was 7.6 and 5.4 respectively. This represents for many patients the availability of a new valuable therapeutic option especially where the occurrence of brain metastases is frequent. Based on the reported data and considering the clinical benefit of the therapy such as prolongation of PFS/OS, a prospective study on the efficacy and safety profile of the tucatinib in the real-world population can be very useful to follow the evolution of HER2- positive metastatic breast cancer with this promising treatment.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To assess the treatment safety and effectiveness as measured by investigator criteria in metastatic breast cancer patients

  Primary endpoint: * Real world Effectiveness of tucatinib/trastuzumab/capecitabine treatments will be collected according to SmPC indication and will include the evaluation in routine clinical practice of: * TTNT (time to next systemic treatment) defined as time from first administration of any study treatment ( i.e. tucatinib/trastuzumab/ capecitabine) to start of a subsequent systemic antineoplastic therapy or death whichever comes first

  From enrollment to the end of follow-up (18 months after tucatinib treatment)

Study Arms (1)

Her2 positive metastatic breast cancer patients

Her2 positive metastatic breast cancer patients who are candidate to tucatinib treatment in real world setting including patients previously treated with trastuzumab, pertuzumab, T-DM1, T-DXd as per authorized therapy setting and NPP/EAP ongoing program.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Her2 positive metastatic breast cancer patients who are candidate to tucatinib treatment in real world setting including patients previously treated with trastuzumab, pertuzumab, T-DM1, T-DXd as per authorized therapy setting and NPP/EAP ongoing program.

You may qualify if:

• Women aged 18 years or older;
• Metastatic breast cancer her2 positive;
• Treatment and treated indication according to local label SmPC and reimbursement for tucatinib-trastuzumab capecitabine treatment;
• At least 2 prior anti her2 treatment in any setting;
• Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.

You may not qualify if:

• Patients with diseases or significant clinical condition, according to the findings of the investigator, may interfere with the study evaluations;
• Absence of any radiological assessment;
• No data on tucatinib efficacy and safety.

Sponsors & Collaborators

• Fondazione Oncotech: lead

Study Sites (30)

AORN S.G. Moscati

Avellino, AV, Italy

RECRUITING

AOU delle Marche

Ancona, Italy

ACTIVE NOT RECRUITING

IRCCS Centro di Riferimento Oncologico (CRO)

Aviano, Italy

RECRUITING

IRCCS Istituto Tumori "Giovanni Paolo II"

Bari, Italy

RECRUITING

Mons. Dimiccoli P.O. Barletta

Barletta, Italy

NOT YET RECRUITING

ASST Papa Giovanni XXIII

Bergamo, Italy

RECRUITING

AORN "Sant'Anna e San Sebastiano" Caserta

Caserta, Italy

RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, Italy

ACTIVE NOT RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, Italy

RECRUITING

Humanitas Istituto Clinico Catanese

Misterbianco, Italy

RECRUITING

A.O. "A. Cardarelli"

Naples, Italy

RECRUITING

AOU Federico II

Naples, Italy

ACTIVE NOT RECRUITING

Istituto Nazionale Tumori "Fondazione G. Pascale"

Naples, Italy

RECRUITING

Istituto Oncologico Veneto I.R.C.C.S.

Padova, Italy

RECRUITING

P.O. "Andrea Tortora"

Pagani, Italy

NOT YET RECRUITING

A.O.U.P. "P. Giaccone"

Palermo, Italy

ACTIVE NOT RECRUITING

ARNAS Civico - Palermo

Palermo, Italy

NOT YET RECRUITING

La Maddalena

Palermo, Italy

NOT YET RECRUITING

Ospedale "Guglielmo Da Saliceto"

Piacenza, Italy

RECRUITING

A.S.L. Napoli 3 SUD - P.O. Apicella

Pollena Trocchia, Italy

NOT YET RECRUITING

AUSL della Romagna - IRST-IRCCS "Dino Amadori"

Rimini, Italy

RECRUITING

A.O.U. Policlinico "Umberto I"

Roma, Italy

NOT YET RECRUITING

Fondazione Universitaria Policlinico Gemelli IRCCS

Roma, Italy

NOT YET RECRUITING

Ospedale "Sandro Pertini" - A.S.L. Roma 2

Roma, Italy

NOT YET RECRUITING

I.R.C.C.S. Istituto Clinico Humanitas

Rozzano, Italy

NOT YET RECRUITING

A.O.U. "San Giovanni di Dio e Ruggi d'Aragona"

Salerno, Italy

NOT YET RECRUITING

Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

NOT YET RECRUITING

A.O.U. "Città della Salute e della Scienza di Torino" - P.O. Sant'Anna

Torino, Italy

NOT YET RECRUITING

Azienda Provinciale Servizi Sanitari di Trento - Ospedale Santa Chiara

Trento, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Michelino De Laurentiis MD

CONTACT

08117770442; m.delaurentiis@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 13, 2026
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

IT (30)