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Trastuzumab to Patients With Advanced Gastric Cancer With HER2 Positive Expression in CTC (GASTHER2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04168931
Recruitment Status : Not yet recruiting
First Posted : November 19, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Rachel Riechelmann, AC Camargo Cancer Center

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Interventional
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.
Drug: Trastuzumab
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




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or over
  • Histological diagnosis of recurrent or metastatic gastric cancer
  • Immunohistochemistry (IHC 0 or 1+) or FISH negative (if IHQ 2+) for HER2 on tissue biopsy, according to institutional routine
  • Candidates to initiate first-line palliative treatment; Previous adjuvant treatment is allowed since its termination occurred at least 12 months ago
  • ECOG performance range 0 to 2
  • Informed consent form signed by patient or legal representative

Exclusion Criteria:

  • Patients already on or previously using anti-HER2 therapy
  • Left ventricular ejection fraction (LVEF) <55% baseline, as already evaluated in the gastric cancer routine
  • Pregnant or lactating women
  • Patients participating in other experimental drug protocols
  • Patients who received previous palliative chemotherapy
  • Another synchronic neoplasia requiring systemic treatment

Information from the National Library of Medicine

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


Contacts
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Contact: Rachel SP Riechelmann, PhD +55 11 2189 5000 ext 2779 rachel.riechelmann@accamargo.org.br
Contact: Mauro DS Donadio, MD +55 11 2189 5000 ext 2779 mauro.donadio@accamargo.org.br

Locations
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Brazil
AC Camargo Cancer Center
São Paulo, SP, Brazil, 01509-010
Contact: Mauro DS Donadio, MD    +55 11 2189 5000 ext 2779    mauro.donadio@accamargo.org.br   
Sponsors and Collaborators
AC Camargo Cancer Center
Investigators
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Principal Investigator: Rachel SP Riechelmann, PhD Head of Clinical Oncology Department
  Study Documents (Full-Text)

Documents provided by Rachel Riechelmann, AC Camargo Cancer Center:
Informed Consent Form  [PDF] November 6, 2019

Publications:

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Responsible Party: Rachel Riechelmann, Head of Clinical Oncology Department, AC Camargo Cancer Center
ClinicalTrials.gov Identifier: NCT04168931    
Other Study ID Numbers: 2793/19
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rachel Riechelmann, AC Camargo Cancer Center:
gastric cancer
HER2
trastuzumab
circulating tumor cells
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents