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

Breast Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04571437
• Other study ID #: MD-127-2019
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: September 2020
• Source: Cairo University
• Contact: Mariam Saleh, M.D
• Phone: +201003677227
• Email: mariamsaleh309[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: April 30, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Estrogen Receptor-positive Breast Cancer
• Metastatic Breast Cancer

Intervention

Drug:
• Capecitabine
Capecitabine metronomic combined with Letrozole
• Letrozole 2.5mg
Letrozole daily alone

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 months Progression free survival rate	Percentage of patients alive and progression-free at 6 months	6 months from the start of treatment
Secondary	Overall response rate	Rate of CR+PR as assessed by the investigator using RECIST 1.1 criteria	6 months from the start of treatment
Secondary	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	6 months from the start of treatment
Secondary	Quality of life assessment using FACIT-B questionnare	FACIT-B questionnare will be completed by each patient at baseline and 6 months after randomization	6 months
Secondary	Median progression free survival	comparison of estimated median PFS between both groups	18 months
Secondary	Time to treatment failure	Time from start treatment to progression, death or treatment discontinuation from any cause	18 months
Secondary	Clinical benefit rate	Complete response + partial response + stable disease for 6 months	After 6 months of treatment
Secondary	Overall survival	Percentage of patients alive at 24 months	24 months
Secondary	Time to chemotherapy adminstration	Time from randomization to the first chemotherapy administration	18 months