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Trial record 96 of 167 for:    pertuzumab

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
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:
  • before treatment initiation
  • before treatment cycle 3 initiation




Primary Outcome Measures :
  1. The rate of patients with conversion of FES negative lesions in FES positive lesions. [ Time Frame: Cycle 3 Day 1 for each patient. ]

Secondary Outcome Measures :
  1. The rate of patients with FES positive lesions before treatment. [ Time Frame: Cycle 4 Day 1 for each patient. ]
  2. 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. ]


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:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC).
  3. Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
  4. Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
  5. OMS ≤ 2.
  6. For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.
  7. Patient affiliated to a Social Health Insurance in France.
  8. Patient must provide written informed consent prior to any study specific procedures.

Exclusion Criteria:

  1. Any previous treatment for metastatic disease.
  2. Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.
  3. Patient with isolated hepatic metastasis.
  4. Patient with hemostasis disorders.
  5. Unbalanced Diabetes.
  6. Patient with usual formal contraindication to PET/TDM Imaging.
  7. Patient who has already started trastuzumab + pertuzumab + taxane treatment.
  8. Pregnant or breastfeeding women.
  9. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
  10. Patient protected by law.

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): NCT03619044


Contacts
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Contact: Florence DALENC, MD-PhD 5 31 15 51 04 dalenc.florence@iuct-oncopole.fr
Contact: Frédéric COURBON, MD-PhD 05 31 15 56 27 courbon.frederic@iuct-oncopole.fr

Locations
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France
Clinique Claude Bernard Not yet recruiting
Albi, France, 81000
Contact: Yann BERGE, MD    05 63 77 77 57    berge@claude-bernard-albi.com   
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    dalenc.florence@iuct-oncopole.fr   
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    cbernardm@clinique-pasteur.com   
Clinique Saint-Jean Du Languedoc Not yet recruiting
Toulouse, France, 31077
Contact: Etienne SUC, MD    05 61 54 90 14    esucsjl@club-internet.fr   
Sponsors and Collaborators
Institut Claudius Regaud

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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03619044     History of Changes
Other Study ID Numbers: 18 SEIN 08
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: August 2018

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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 Institut Claudius Regaud:
Metastatic breast cancer
FES-PET
HER2-positive Breast Cancer

Additional relevant MeSH terms:
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Pertuzumab
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Taxane
Estrogens
Antineoplastic Agents, Immunological
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs