A Phase II Study of Ovarian Function Suppression And ExemesTane with or without PalbocIclib in PreMenopausal Women with ER positive / HER-2 negative MetAstatic Breast Cancer

AMCI (Africa Middle East Cancer Intergroup)/Investigator Initiated Research0 sites160 target enrollmentMarch 5, 2019

ConditionsMetastatic Breast Cancer – Oncology Not applicable T51.2

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Metastatic Breast Cancer – Oncology
Sponsor: AMCI (Africa Middle East Cancer Intergroup)/Investigator Initiated Research
Enrollment: 160
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 5, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

Female

Investigators

Sponsor

AMCI (Africa Middle East Cancer Intergroup)/Investigator Initiated Research

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all the following inclusion criteria to be eligible for enrolment into the study:
•1\. Adult women (\= 18 years of age) with metastatic or locally advanced breast cancer (histologically or cytologically proven diagnosis of adenocarcinoma of the breast) not amenable to curative treatment by surgery or radiotherapy.
•2\. ER positive tumour: Histological or cytological confirmation of estrogen and/or progesterone\-receptor positive, as determined by routine IHC. Positivity is defined as \=1% positive stained cells. The receptor status determined by utilizing an assay consistent with local laboratory standards.
•3\. HER2 negative breast cancer as confirmed by IHC, SISH or FISH.
•4\. Premenopausal women : (definition of a real menopause is not a simple task in these relatively young women, owing to the potential effect of prior chemotherapy and /or endocrinal therapy particularly OFS) defined either by:
•i. Any age below 40 years , irrespective to E2 level or menstrual history
•ii. If the woman had a menstrual period any time within the last 12 months
•iii. If the woman has amenorrhea of more than 12 months (in the absence of chemotherapy or ovarian function suppression) that is associated with serum hormone levels that are NOT in the postmenopausal range (either estradiol (E2\) \< 30 pg/mL and follicle\-stimulating hormone (FSH) \< 20 mU/mL OR E2 \= 30 pg/mL and FSH \= 20 mU/mL) \[30].
•5\. Secondary hormonal resistance to tamoxifen or endocrinal sensitive metastatic disease
•i. Secondary hormonal resistance is defined as recurrence after 24 months from the start of adjuvant tamoxifen treatment or within 12 months from the end of the 5 years of adjuvant Tamoxifen

Exclusion Criteria

•Subjects presenting with any of the following will not be included in the study:
•1\. Postmenopausal women. Postmenopausal status is defined by age\>40years with amenorrhea of more than 12 months, associated with serum hormonal levels of the postmenopausal range (either estradiol (E2\) \< 30 pg/mL and follicle\-stimulating hormone (FSH) \< 20 mU/mL or E2 \= 30 pg/mL and FSH \= 20 mU/mL) \[30], in the absence of chemotherapy, tamoxifen, or OFS.
•2\. Patients with primary endocrinal resistance, defined as recurrence within 24 months from the start of adjuvant tamoxifen treatment.
•3\. Symptomatic and/or life threatening visceral metastases
•1\. Diffuse lymphangitic carcinomatosis.
•2\. Bulky liver or pulmonary metastases
•4\. Patients with only non\-measurable lesions other than bone metastasis as defined above (e.g., pleural effusion, ascites, etc.).
•5\. Patients who have received hormonal treatment other than neo/adjuvant tamoxifen ± LHRH agonist for their early breast cancer.
•6\. Patients who received prior chemotherapy for metastatic or recurrent breast cancer.
•7\. Another malignancy within 5 years prior to enrolment with the exception of adequately treated in\-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non\-melanomatous skin cancer.