Overview

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

Status:
Recruiting
Trial end date:
2022-04-30
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cairo University
Treatments:
Capecitabine
Letrozole
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.