HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer (HOTBreast)

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Female; Hormone Dependent Neoplasms
• Intervention / Treatment: Drug: Aromatase Inhibitors

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

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal
    • Hospital São Francisco Xavier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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: Aromatase Inhibitor
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: Aromatase Inhibitor
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: Aromatase Inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Biology	Effects of neoadjuvant aromatase inibitors on tumor biology in terms of RE,PR,Ki 67 measuring the after IA presurgical values	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Pathology response	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	6 weeks
Disease free survival	Effects of neoadjuvant aromatase inibitors on disease free survival the first, fifth and tenth years of follow-up	1 5 and 10 years
Hormone treatment	Disease stability or progression under Hormone treatment in patients under active surveillance. Clinical and immaging follow up	1 5 and 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical outome	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	3 days 1 month and 3 months

Collaborators and Investigators

• Sponsor: Centro Hospitalar Lisboa Ocidental
• Investigators: Principal Investigator: Vasco Fonseca, MD, CHLO Medical Oncology dpt; Principal Investigator: Zacharoula Sidiropoulou, CHLO Surgery dpt

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Aromatase inhibitors; Luminal Breast Cancer neoadjuvant hormone therapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Neoplasms, Hormone-Dependent; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Estrogen Antagonists; Aromatase Inhibitors
• Other Study ID Numbers: CentroHLOBreastUnit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No