The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane. (REVER)
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|ClinicalTrials.gov Identifier: NCT03619044|
Recruitment Status : Not yet recruiting
First Posted : August 7, 2018
Last Update Posted : March 29, 2019
This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.
For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).
Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.
Patients will be followed during the 3 cycles of treatment.
|Condition or disease||Intervention/treatment||Phase|
|HER2-positive Breast Cancer||Other: 2 FES-PET Imaging will be performed:||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
Patients with metastatic breast cancer
Patients with metastatic breast cancer treated with trastuzumab + pertuzumab + taxane in the metastatic first line.
Other: 2 FES-PET Imaging will be performed:
- The rate of patients with conversion of FES negative lesions in FES positive lesions. [ Time Frame: Cycle 3 Day 1 for each patient. ]
- The rate of patients with FES positive lesions before treatment. [ Time Frame: Cycle 4 Day 1 for each patient. ]
- The adverse events due to FES-PET imaging evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. [ Time Frame: Cycle 4 Day 1 for each patient. ]
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): NCT03619044
|Contact: Florence DALENC, MD-PhD||5 31 15 51 firstname.lastname@example.org|
|Contact: Frédéric COURBON, MD-PhD||05 31 15 56 email@example.com|
|Clinique Claude Bernard||Not yet recruiting|
|Albi, France, 81000|
|Contact: Yann BERGE, MD 05 63 77 77 57 firstname.lastname@example.org|
|Centre Hospitalier Auch|
|Auch, France, 32008|
|Centre Hospitalier de Rodez||Not yet recruiting|
|Rodez, France, 12000|
|Contact: Véronique FABRE, MD 05 65 55 12 12 VE.FABRE@ch-rodez.fr|
|IUCT-O||Not yet recruiting|
|Toulouse, France, 31059|
|Contact: Florence DALENC, MD-PhD 05 31 15 51 22 email@example.com|
|Contact: Frédéric COURBON, MD-PhD 05 31 15 56 27 Courbon.Frederic@iuct-oncopole.fr|
|Clinique Pasteur||Not yet recruiting|
|Toulouse, France, 31076|
|Contact: Chantal BERNARD-MARTY, MD 05 67 20 44 01 firstname.lastname@example.org|
|Clinique Saint-Jean Du Languedoc||Not yet recruiting|
|Toulouse, France, 31077|
|Contact: Etienne SUC, MD 05 61 54 90 14 email@example.com|