Hormone Therapy Initiation Immediately After Histological Diagnosis of Breast Cancer, Can it Make Any Difference?
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Tumor Biology
Study Overview
Brief Summary
Breast Cancer is a public health issue worldwide. The time from diagnosis to treatment initiation varies from country to country and regionally within a country. Early diagnosis and prompt treatment initiation are key factors in patient survival rates.
Currently there is a rising trend, with a high percentage of patients with "Luminal" like breast cancer only undergoing adjuvant endocrine therapy.
Authors argue that tumor biology alterations after introducing very early endocrine therapy might have a prognostic and therapeutic impact and should be studied.
Detailed Description
Selected patients of female gender, above 50 y.o, and after a biopsy of Luminal-like Breast Cancer will go under aromatase inhibitor, from the diagnosis day till the surgical therapy to be decided (if so).In this study are going to be included patients that refuse surgical treatment, remaining this way in an "active surveillance". This last group is going to be randomised in order to recieve hormontherapy plus placebo vs hormontherapy plus acetolisalicilic acid.
In this way, authors want to investigate if:
- st This approach influences the tumor biology
- nd This approach influences tumor pathologic response and progression free survival.
- rd It is a valid approach and in which grade, for patients that refuse surgical treatment
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Menopausal woman of equal or above 50 y.o. with breast biopsy of Luminal like breast carcinoma
Exclusion Criteria
- •informed consent
- •<50 y.o.
- •Pre-menopausal state
Arms & Interventions
Aromatase Inhibitor group
Female patients of 50 and above y.o. shall initiate hormone therapy (Letrozol 2.5 mg or Anastrazol 1 mg) immediately after the diagnosis until surgery.
Intervention: Aromatase Inhibitors (Drug)
Aromatase Inhibitor Active surveillance
Female patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht
Intervention: Aromatase Inhibitors (Drug)
Aromatase Inhibitor Active surveillance + aas
emale patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg plus acetilsalicilic acid) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht
Intervention: Aromatase Inhibitors (Drug)
Outcomes
Primary Outcomes
Tumor Biology
Time Frame: 6 weeks
Effects of neoadjuvant aromatase inibitors on tumor biology in terms of RE,PR,Ki 67 measuring the after IA presurgical values
Secondary Outcomes
- Tumor Pathology response(6 weeks)
- Disease free survival(1 5 and 10 years)
- Hormone treatment(1 5 and 10 years)
Investigators
Zacharoula Sidiropoulou
Principal investigator
Centro Hospitalar Lisboa Ocidental