HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer
- Conditions
- Breast Cancer FemaleHormone Dependent Neoplasms
- Interventions
- Drug: Aromatase Inhibitors
- Registration Number
- NCT03111615
- Lead Sponsor
- Centro Hospitalar Lisboa Ocidental
- 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:
1. st This approach influences the tumor biology
2. nd This approach influences tumor pathologic response and progression free survival.
3. rd It is a valid approach and in which grade, for patients that refuse surgical treatment
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 90
Menopausal woman of equal or above 50 y.o. with breast biopsy of Luminal like breast carcinoma
- informed consent
- <50 y.o.
- Pre-menopausal state
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aromatase Inhibitor group Aromatase Inhibitors 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. Aromatase Inhibitor Active surveillance Aromatase Inhibitors 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 Aromatase Inhibitor Active surveillance + aas Aromatase Inhibitors 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
- Primary Outcome Measures
Name Time Method Tumor Biology 6 weeks Effects of neoadjuvant aromatase inibitors on tumor biology in terms of RE,PR,Ki 67 measuring the after IA presurgical values
- Secondary Outcome Measures
Name Time Method Tumor Pathology response 6 weeks Effects of neoadjuvant aromatase inibitors on tumor pathologic response , in terms of breast imaging re-avaliation before surgical intervention. For patients that refuse surgery or extend hormone therapy for other reasons
Disease free survival 1 5 and 10 years Effects of neoadjuvant aromatase inibitors on disease free survival the first, fifth and tenth years of follow-up
Hormone treatment 1 5 and 10 years Disease stability or progression under Hormone treatment in patients under active surveillance. Clinical and immaging follow up
Trial Locations
- Locations (1)
Hospital São Francisco Xavier
🇵🇹Lisbon, Portugal
Hospital São Francisco Xavier🇵🇹Lisbon, PortugalMargarida Brito, MDSub Investigator