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Capecitabine in Combination With Aromatase Inhibitor Versus Aromatase Inhibitors, in Hormonal Receptor Positive Recurrent or Metastatic Breast Cancer Patients, Randomized Controlled Study (CONCEPT)

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ClinicalTrials.gov Identifier: NCT04012918
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Hesham Elghazaly,MD, Ain Shams University

Brief Summary:
Women with recurrent or metastatic breast cancer who are hormone receptor positive are candidates for first line hormonal therapy including aromatase inhibitors. In the past few years new combination therapies became available as fulvastrant or palbociclib with letrezole; increasing the progression free survival (PFS). A retrospective study showed that combination of capecitabine with aromatase inhibitors increase PFS as 1st and 2nd line line treatment another prospective study showed the same results. The aim of our study is confirm such data by a randomized controlled trial.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Capecitabine plus aromatase inhibitor Drug: A.I. Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Capecitabine in Combination With Aromatase Inhibitor Versus Aromatase Inhibitors, in Hormonal Receptor Positive Recurrent or Metastatic Breast Cancer Patients, Randomized Controlled Study (CONCEPT Trial)
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: A.I. + Capeciabine
Patients will receive Capecitabine 625 mg/m2 bid PO for 14 days to be repeated every 21 days until progression in combination with aromatase inhibitor if postmenopausal, addition of LHRH agonist will be added if premenopausal.
Drug: Capecitabine plus aromatase inhibitor
Capecitabine 625 mg/m2 bid PO for 14 days to be repeated every 21 days until progression in combination with aromatase inhibitor if postmenopausal, addition of LHRH agonist will be added if premenopausal.

Active Comparator: A.I
Patients will receive aromatase inhibitors ( letrozole 2.5 mg PO per day or Anastrozole 1 mg PO per day or aromasin 25 mg PO per day) if post-menopausal, if premenopausal leutnising hormone releasing hormone (LHRH) agonist will be added to the aromatase inhibitor.
Drug: A.I.
aromatase inhibitors ( letrozole 2.5 mg PO per day or Anastrozole 1 mg PO per day or aromasin 25 mg PO per day) if post-menopausal, if premenopausal leutnising hormone releasing hormone (LHRH) agonist will be added to the aromatase inhibitor




Primary Outcome Measures :
  1. Progress-free survival [ Time Frame: up to 24 months ]
    Time from randomization to the first documentation of objective tumor progression or to death due to any cause or Intolerable toxicity.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: till progression or up to 24 months whichever earlier ]
    Detailed Description and grading of adverse events



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   participants are chosen on self-representation of gender identity
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy
  2. Eastern Cooperative Oncology Group (ECOG) 0-2
  3. Hormone receptor positive
  4. No prior systemic anti-cancer therapy for advanced ER+ disease ( hormonal therapy)
  5. Measurable disease defined by revised RECIST criteria (version 1.1), or bone-only disease
  6. normal laboratory values
  7. Postmenopausal or premenopausal with oophorectomy (medical or surgical).

Exclusion Criteria:

  1. Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
  2. Prior (neo) adjuvant treatment with same aromatase inhibitor type with DFI =< 12 months from completion of treatment.
  3. Known uncontrolled or symptomatic central nervous system metastases
  4. Second primary malignancy
  5. Serious uncontrolled intercurrent infections or intercurrent medical or psychiatric illness
  6. unable to swallow tablets, or malabsorption patients.
  7. unwilling or unable to comply with study protocol or unable to meet the follow up.
  8. patients who researchers considered were not suitable to participate.

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): NCT04012918


Contacts
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Contact: Nada Naguib 01221222573 ext +2 nada_naguib@yahoo.com
Contact: Hesham Elghazaly 01001300236 ext +2 heshamelghazaly@hotmail.com

Locations
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Egypt
Clinical oncology department, Faculty of medicine, Ain Shams University Recruiting
Cairo, Egypt, 11817
Contact: Nada Naguib, Assistant lecturer    1221222573      
Sub-Investigator: Nagy Samy Gobran         
Sub-Investigator: Ramy Refaat Ghali         
Sub-Investigator: Reham Mohamed Faheim         
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Hesham Elghazaly, Professor Ain Shams University

Additional Information:
Publications:
Alvarado Miranda, A. et al. (2012) 'Combination treatment with aromatase inhibitor and capecitabine as first- or second-line treatment in metastatic breast cancer.', Journal of Clinical Oncology. American Society of Clinical Oncology, 30(15_suppl), pp. e11016-e11016. doi: 10.1200/jco.2012.30.15_suppl.e11016.
L., J. et al. (2015) 'Phase II clinical trial of metronomic oral capecitabine therapy combined with aromatase inhibitors in postmenopausal metastatic and recurrent breast cancer resistant to first-line aromatase inhibitors', European Journal of Cancer, 51(March), p. S281. doi: 10.1016/S0959-8049(16)30798-5.
• Pritchard, K. I. et al. (2012) 'Everolimus in Postmenopausal Hormone- Receptor-Positive Advanced Breast Cancer', Nejm, pp. 1-10. doi: 10.1056/NEJMoa1109653.

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Responsible Party: Hesham Elghazaly,MD, professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04012918     History of Changes
Other Study ID Numbers: Combined CTH and HT in MBC
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Hesham Elghazaly,MD, Ain Shams University:
chemotherapy
aromatase inhibitor
capecitabine
hormonal therapy

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Aromatase Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs