Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Hormones

Letrozole

Antimetabolites

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

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

Capecitabine metronomic combined with Letrozole

Letrozole 2.5mg

Mariam Saleh, M.D

Loay Kassem, M.D

Mariam A Saleh, M.D

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.

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.

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

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

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.

Percentage of patients alive and progression-free at 6 months

Rate of CR+PR as assessed by the investigator using RECIST 1.1 criteria

Rates of all grade (grade 1-4) and high grade (grade 3+4) adverse events as assessed by NCI-CTAE v4.0

FACIT-B questionnare will be completed by each patient at baseline and 6 months after randomization

comparison of estimated median PFS between both groups

Time from start treatment to progression, death or treatment discontinuation from any cause

Complete response + partial response + stable disease for 6 months

Percentage of patients alive at 24 months

Time from randomization to the first chemotherapy administration

Cairo University

Assistant lecturer

Menopause

Mitogens

Anastrozole

Antineoplastic Agents, Hormonal

ARV-471 taken once daily until surgical resection

Anastrozole 1mg taken once daily until surgical resection

ARV-471

Participants will have surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)

Surgical resection of breast tumor

This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with ER+/HER2- localized breast cancer.

This is a Phase 2, open-label, randomized, non-comparative proof of concept study of ARV-471 or anastrozole in participants with ER+/HER2- breast cancer amenable to definitive surgical resection. The main goal of this study is to evaluate the biological activity of ARV-471 and anastrozole, respectively.

A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery

An Open-label, Randomized, Non-comparative Phase 2 Study of ARV-471 or Anastrozole in Post-menopausal Women With ER+/HER2- Breast Cancer in the Neoadjuvant Setting

Percent change in Ki-67 expression between baseline and C1D15 tumor biopsies

Incidence of all adverse events, serious adverse events, and adverse events leading to study drug discontinuation

Pathologic stage at the time of surgical resection

pathologic complete response rate at the time of surgical resection

modified Pre-operative Endocrine Prognostic Index score at the time of surgical resection

radiographical response rate in the primary tumor during cycle 6

Best percentage change from baseline up to C6D1 in caliper measurement of the primary tumor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)	NCT04571437	Breast Cancer Estrogen Recept... Metastatic Brea...	Capecitabine Letrozole 2.5mg	18 Years - 70 Years	Cairo University
A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery	NCT05549505	Breast Cancer	ARV-471 Anastrozole Surgical resect...	18 Years -	Arvinas Inc.

Spots Global Cancer Trial Database for hormone positive