HOTBreast: HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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:
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st This approach influences the tumor biology
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nd This approach influences tumor pathologic response and progression free survival.
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rd It is a valid approach and in which grade, for patients that refuse surgical treatment
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Aromatase Inhibitors
Aromatase Inhibitor to start immediately after diagnosis of a Luminal Invasive Breast Carcinoma Patients will be given Letrozol 2.5 mg or Anastrazol1 mg, every 24H and all of them will be given Calcium + Vit D supplement.
Venlafaxin 75 mg is to be administrated cases indicated
Other Names:
|
| No Intervention: Control group Female patients of 50 and above y.o. that follow standard protocol (no pre-surgery (Letrozol 2.5 mg or Anastrazol 1 mg)) |
|
| Other: 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 |
Drug: Aromatase Inhibitors
Aromatase Inhibitor to start immediately after diagnosis of a Luminal Invasive Breast Carcinoma Patients will be given Letrozol 2.5 mg or Anastrazol1 mg, every 24H and all of them will be given Calcium + Vit D supplement.
Venlafaxin 75 mg is to be administrated cases indicated
Other Names:
|
| Other: 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 |
Drug: Aromatase Inhibitors
Aromatase Inhibitor to start immediately after diagnosis of a Luminal Invasive Breast Carcinoma Patients will be given Letrozol 2.5 mg or Anastrazol1 mg, every 24H and all of them will be given Calcium + Vit D supplement.
Venlafaxin 75 mg is to be administrated cases indicated
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Other Outcome Measures
- Surgical outome [3 days 1 month and 3 months]
Eventual influence of the aromatase inibitor in the surgical procedure (time, bleeding, scaring, infections, seroma formation, sentinel node detection and axillary response) is to be evaluated
Eligibility Criteria
Criteria
Inclusion Criteria: Menopausal woman of equal or above 50 y.o. with breast biopsy of Luminal like breast carcinoma
Exclusion Criteria:
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informed consent
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<50 y.o.
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Pre-menopausal state
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital São Francisco Xavier | Lisbon | Portugal |
Sponsors and Collaborators
- Centro Hospitalar Lisboa Ocidental
Investigators
- Principal Investigator: Vasco Fonseca, MD, CHLO Medical Oncology dpt
- Principal Investigator: Zacharoula Sidiropoulou, CHLO Surgery dpt
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CentroHLOBreastUnit