Clinical trial NCT04571437: Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Estrogen Receptor-positive Breast Cancer
Metastatic Breast Cancer
Keywords: Advanced breast cancer
chemo-hormonal
hormone positive
metronomic capecitabine
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are assigned into two arms of treatment, arm A contains Letrozole and metronomic Capecitabine while arm B contains Letrozole alone.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 6 months Progression free survival rate
timeFrame: 6 months from the start of treatment
Secondary outcomes:
measure: Overall response rate
timeFrame: 6 months from the start of treatment
measure: Adverse events rates in both groups
timeFrame: 6 months from the start of treatment
measure: Quality of life assessment using FACIT-B questionnare
timeFrame: 6 months
measure: Median progression free survival
timeFrame: 18 months
measure: Time to treatment failure
timeFrame: 18 months
measure: Clinical benefit rate
timeFrame: After 6 months of treatment
measure: Overall survival
timeFrame: 24 months
measure: Time to chemotherapy adminstration
timeFrame: 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Mariam Saleh, M.D
role: PRINCIPAL_INVESTIGATOR
References: