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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Estrogen Receptor-positive Breast Cancer Metastatic Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are assigned into two arms of treatment, arm A contains Letrozole and metronomic Capecitabine while arm B contains Letrozole alone.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemo endocrine treatment (A)

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

Group Type ACTIVE_COMPARATOR

Capecitabine

Intervention Type DRUG

Capecitabine metronomic combined with Letrozole

Letrozole 2.5mg

Intervention Type DRUG

Letrozole daily alone

Endocrine treatment only (B)

Letrozole 2.5mg PO daily

Group Type ACTIVE_COMPARATOR

Letrozole 2.5mg

Intervention Type DRUG

Letrozole daily alone

Interventions

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Capecitabine

Capecitabine metronomic combined with Letrozole

Intervention Type DRUG

Letrozole 2.5mg

Letrozole daily alone

Intervention Type DRUG

Other Intervention Names

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Xeloda Femara

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No