Clinical trial NCT02995772: Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients
Official title: Preoperative Neoadjuvant Hormonal Therapy and Neoadjuvant Chemotherapy for Stage IIIB and IV Breast Cancer Patients in Dharmais National Cancer Center Hospital, Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Dharmais National Cancer Center Hospital
Sponsor class: OTHER_GOV
First posted: 2016-12-16
Enrollment: 122
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT)

Detailed description: This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT) between 2011 and 2016.

The primary end points are overall survival (OS) and progression free survival (PFS) with Kaplan Meier.

This study was approved by Ethical Committee in Dharmais National Cancer Hospital.

Eligibility criteria: Inclusion Criteria:

* IIIB/C and IV stage of breast cancer
* received neoadjuvant hormonal therapy or neoadjuvant chemotherapy
* had first and second biopsy (surgery) within 6 months

Exclusion Criteria:

* had mastectomy before treatment
* pregnant
* disagree to enter the study
* had been given hormonal therapy or chemotherapy before study
* had contra-indication of SOB for pre-menopausal patients

Primary outcomes:
measure: Overall survival
timeFrame: time from the date of pathological diagnosis until death from any cause and until minimum sample sizes are met and an average 3 years
Secondary outcomes:
measure: Progressive free survival
timeFrame: time from after treatment until tumor progression or death from any cause and until minimum sample sizes are met and an average 3 years
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Dharmais National Cancer Center Hospital
Study officials:
affiliation: Dharmais National Cancer Center Hospital
name: Ramadhan Karsono, Doctoral
role: STUDY_CHAIR
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