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Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study) (B-001)

Primary Purpose

Breast Cancer, Estrogen Receptor-positive Breast Cancer, Metastatic Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Capecitabine
Letrozole 2.5mg
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Advanced breast cancer, chemo-hormonal, hormone positive, metronomic capecitabine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female sex
  • Age 18-70
  • ECOG-PS 0-II.
  • Histopathological proof of breast cancer
  • ER positive (Allred score of ≥3 out of 8), and HER2 negative by IHC (or ISH if HER2 +2).
  • Metastatic/recurrent disease as proven by CT scan, bone scan or clinical examination (for skin lesions). Biopsy of the recurrent lesions is encouraged but not mandatory.
  • Either hormone sensitive setting (Denovo metastatic disease or disease progression after more than 1 year of ending adjuvant endocrine therapy) or secondary resistance to tamoxifen therapy (disease relapse after more than 2 years of starting and less than 1 year of ending adjuvant endocrine therapy, or DP of metastatic disease after more than 6 months of first line tamoxifen).
  • Adequate organ function.
  • Signed informed consent

Exclusion criteria:

  • Inadequate organ functions.
  • Disease progression while on prior aromatase inhibitor therapy.
  • Primary endocrine resistance.
  • Double primary cancer (history of other malignancy apart from a non melanoma skin cancer).
  • Refusal to sign consent.

Sites / Locations

  • Faculty of Medicine, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Chemo endocrine treatment (A)

Endocrine treatment only (B)

Arm Description

Letrozole 2.5mg PO daily + Capecitabine 500mg/m2 bid PO continously

Letrozole 2.5mg PO daily

Outcomes

Primary Outcome Measures

6 months Progression free survival rate
Percentage of patients alive and progression-free at 6 months

Secondary Outcome Measures

Overall response rate
Rate of CR+PR as assessed by the investigator using RECIST 1.1 criteria
Adverse events rates in both groups
Rates of all grade (grade 1-4) and high grade (grade 3+4) adverse events as assessed by NCI-CTAE v4.0
Quality of life assessment using FACIT-B questionnare
FACIT-B questionnare will be completed by each patient at baseline and 6 months after randomization
Median progression free survival
comparison of estimated median PFS between both groups
Time to treatment failure
Time from start treatment to progression, death or treatment discontinuation from any cause
Clinical benefit rate
Complete response + partial response + stable disease for 6 months
Overall survival
Percentage of patients alive at 24 months
Time to chemotherapy adminstration
Time from randomization to the first chemotherapy administration

Full Information

First Posted
September 25, 2020
Last Updated
September 25, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04571437
Brief Title
Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)
Acronym
B-001
Official Title
Letrozole With or Without Metronomic Capecitabine in First Line Treatment of Patients With ER-positive HER2 Negative Advanced Breast Cancer: A Randomized Phase II Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

Brief Summary
A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.
Detailed Description
This is a randomized clinical trial that assigns patients with female breast cancer in the metastatic entity or advanced -beyond local disease treatment - entity into two arms. Arm A contains Letrozole with metronomic Capecitabine versus arm B that contains Letrozole alone. This is to be applied on ER positive HER2 negative tumours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Estrogen Receptor-positive Breast Cancer, Metastatic Breast Cancer
Keywords
Advanced breast cancer, chemo-hormonal, hormone positive, metronomic capecitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients are assigned into two arms of treatment, arm A contains Letrozole and metronomic Capecitabine while arm B contains Letrozole alone.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemo endocrine treatment (A)
Arm Type
Active Comparator
Arm Description
Letrozole 2.5mg PO daily + Capecitabine 500mg/m2 bid PO continously
Arm Title
Endocrine treatment only (B)
Arm Type
Active Comparator
Arm Description
Letrozole 2.5mg PO daily
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine metronomic combined with Letrozole
Intervention Type
Drug
Intervention Name(s)
Letrozole 2.5mg
Other Intervention Name(s)
Femara
Intervention Description
Letrozole daily alone
Primary Outcome Measure Information:
Title
6 months Progression free survival rate
Description
Percentage of patients alive and progression-free at 6 months
Time Frame
6 months from the start of treatment
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Rate of CR+PR as assessed by the investigator using RECIST 1.1 criteria
Time Frame
6 months from the start of treatment
Title
Adverse events rates in both groups
Description
Rates of all grade (grade 1-4) and high grade (grade 3+4) adverse events as assessed by NCI-CTAE v4.0
Time Frame
6 months from the start of treatment
Title
Quality of life assessment using FACIT-B questionnare
Description
FACIT-B questionnare will be completed by each patient at baseline and 6 months after randomization
Time Frame
6 months
Title
Median progression free survival
Description
comparison of estimated median PFS between both groups
Time Frame
18 months
Title
Time to treatment failure
Description
Time from start treatment to progression, death or treatment discontinuation from any cause
Time Frame
18 months
Title
Clinical benefit rate
Description
Complete response + partial response + stable disease for 6 months
Time Frame
After 6 months of treatment
Title
Overall survival
Description
Percentage of patients alive at 24 months
Time Frame
24 months
Title
Time to chemotherapy adminstration
Description
Time from randomization to the first chemotherapy administration
Time Frame
18 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female sex Age 18-70 ECOG-PS 0-II. Histopathological proof of breast cancer ER positive (Allred score of ≥3 out of 8), and HER2 negative by IHC (or ISH if HER2 +2). Metastatic/recurrent disease as proven by CT scan, bone scan or clinical examination (for skin lesions). Biopsy of the recurrent lesions is encouraged but not mandatory. Either hormone sensitive setting (Denovo metastatic disease or disease progression after more than 1 year of ending adjuvant endocrine therapy) or secondary resistance to tamoxifen therapy (disease relapse after more than 2 years of starting and less than 1 year of ending adjuvant endocrine therapy, or DP of metastatic disease after more than 6 months of first line tamoxifen). Adequate organ function. Signed informed consent Exclusion criteria: Inadequate organ functions. Disease progression while on prior aromatase inhibitor therapy. Primary endocrine resistance. Double primary cancer (history of other malignancy apart from a non melanoma skin cancer). Refusal to sign consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariam Saleh, M.D
Phone
+201003677227
Email
mariamsaleh309@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Loay Kassem, M.D
Phone
+201003022907
Email
loay.kassem@cairocure.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariam Saleh, M.D
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam A Saleh, M.D
Phone
+201003677227
Email
mariamsaleh309@gmail.com
First Name & Middle Initial & Last Name & Degree
Loay Kassem, M.D
Phone
+201003022907
Email
loay.kassem@cairocure.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)

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