Trastuzumab to Patients With Advanced Gastric Cancer With HER2 Positive Expression in CTC (GASTHER2)
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|ClinicalTrials.gov Identifier: NCT04168931|
Recruitment Status : Not yet recruiting
First Posted : November 19, 2019
Last Update Posted : November 19, 2019
BACKGROUND: Gastric cancer is one of the most common cancers and is one of the most deadly cancers. Most patients have advanced disease and should receive first-line trastuzumab-associated chemotherapy when the biopsy is positive for immunocytochemical expression and / or HER2 gene amplification. A study conducted by our group noted that there may be disagreement in HER2 expression between circulating tumor cells (CTCs) and tumor tissue. However, the effectiveness of using anti-HER2 treatment when only CTC express HER2 is unknown. The present study aims to evaluate the expression of HER2 in patients with relapsed or metastatic gastric cancer and what would be the efficacy of adding trastuzumab to chemotherapy when tumor tissue is negative for HER2, but there is expression of this gene in CTCs.
OBJECTIVES: The primary objectives are to evaluate HER2 expression in circulating tumor cells of relapsed or metastatic gastric cancer patients with negative HER2 expression on tissue biopsy and response to standard treatment with combined anti-HER2 chemotherapy in this population. Secondary objectives are to assess the prognostic impact of HER2 positivity on circulating tumor cells in advanced gastric tumors and to evaluate HER2 expression in CTCs at the time of treatment progression.
METHODS: The investigators will prospectively evaluate HER2 expression in CTC and its response to treatment with standard chemotherapy and addition of trastuzumab in patients with relapsed or metastatic gastric cancer with positive expression of HER2 only in CTC. HER2 expression in tissue and in CTC will be evaluated by immunocytochemistry. Descriptive statistics will be used to report the results of categorical and continuous variables, and respective dispersion measures. Time-to-event variables will be reported in Kaplan Meyer medians and curves.
EXPECTED RESULTS: Upon completion of the study the investigators expect to show the frequency of HER2 expression in this specific population, higher radiological response rate with trastuzumab combination compared to chemotherapy alone, determine the prognostic impact associated with HER2 expression in CTCs and show the frequency of HER2 expression in CTCs at the time of study treatment progression. This study may open a new opportunity for anti-HER2 treatment for gastric cancer patients.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Stage IV||Drug: Trastuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single-phase prospective unicentric phase II study evaluating HER2 expression in circulating tumor cells and their response to standard treatment with trastuzumab combination chemotherapy in cases of positive expression in patients with relapsed or metastatic gastric cancer with expression HER2 negative in the tumor tissue.|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Adding Trastuzumab to Standard Chemotherapy in Patients With Advanced HER2-negative Gastric Cancer and HER2 Positive Expression in Circulating Tumor Cells|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2025|
Use of trastuzumab combination chemotherapy in patients with relapsed or metastatic gastric cancer with expression HER2 negative in the tumor tissue but positive in CTC.
The first-line standard treatment for gastric cancer is based on fluoropyrimidine and platinum-containing chemotherapy (FOLFOX). When the tumor expresses HER2 3+ on IHC or 2+ and is confirmed by FISH, trastuzumab at the standard dose of 8 mg / kg in D1 of the first cycle is added, followed by 6 mg / kg every 2 weeks for the remaining cycles until disease progression, unacceptable toxicity. (3) We will use the same doses of trastuzumab, but HER2 positivity is determined by immunocytochemical expression and FISH in CTCs for patients with negative expression in tissue biopsy.
Other Name: Experimental group
- Radiological response rate [ Time Frame: through study completion, an average of 5 years ]RECIST1.1 radiological response rate following standard treatment with combined chemotherapy with trastuzumab in relapsed or metastatic gastric cancer with positive expression of HER2 in CTC and negative in tumor tissue.
- Frequency of HER2 expression [ Time Frame: at screening before Day 1 Cycle 1 (each cycle is 14 days) ]Frequency of HER2 expression among circulating tumor cells of patients with relapsed or metastatic gastric cancer with negative expression of HER2 in tumor tissue
- Frequency of HER2 expression [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 60 months ]Frequency of HER2 expression among circulating tumor cells of patients with relapsed or metastatic gastric cancer with negative expression of HER2 in tumor tissue
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04168931
|Contact: Rachel SP Riechelmann, PhD||+55 11 2189 5000 ext firstname.lastname@example.org|
|Contact: Mauro DS Donadio, MD||+55 11 2189 5000 ext email@example.com|
|AC Camargo Cancer Center|
|São Paulo, SP, Brazil, 01509-010|
|Contact: Mauro DS Donadio, MD +55 11 2189 5000 ext 2779 firstname.lastname@example.org|
|Principal Investigator:||Rachel SP Riechelmann, PhD||Head of Clinical Oncology Department|