HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer

Hormone Therapy Initiation Immediately After Histological Diagnosis of Breast Cancer, Can it Make Any Difference?

Sponsors

Lead Sponsor: Centro Hospitalar Lisboa Ocidental

Source 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

Overall Status Unknown status
Start Date 2018-05-01
Completion Date 2020-05-01
Primary Completion Date 2019-05-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Tumor Biology 6 weeks
Secondary Outcome
Measure Time Frame
Tumor Pathology response 6 weeks
Disease free survival 1 5 and 10 years
Hormone treatment 1 5 and 10 years
Enrollment 90
Condition
Intervention

Intervention Type: Drug

Intervention Name: Aromatase Inhibitors

Description: 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 Name: Aromatase Inhibitor

Eligibility

Criteria:

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

Gender:

Female

Gender Based:

Yes

Gender Description:

female sex

Minimum Age:

50 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Vasco Fonseca, MD

Phone: 0035121 043 1000

Email: [email protected]

Location
Facility: Investigator: Hospital São Francisco Xavier Margarida Brito, MD Sub-Investigator
Location Countries

Portugal

Verification Date

2017-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Centro Hospitalar Lisboa Ocidental

Investigator Full Name: Zacharoula Sidiropoulou

Investigator Title: Principal investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Aromatase Inhibitor group

Type: Experimental

Description: 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.

Label: Control group

Type: No Intervention

Description: Female patients of 50 and above y.o. that follow standard protocol (no pre-surgery (Letrozol 2.5 mg or Anastrazol 1 mg))

Label: Aromatase Inhibitor Active surveillance

Type: Other

Description: 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

Label: Aromatase Inhibitor Active surveillance + aas

Type: Other

Description: 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

Acronym HOTBreast
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Aromatase inibitor therapy to start immediately after biopsy results are available Letrozole 2.5mg or Anastrazol 1 mg

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

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