HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer

NCT03111615 | Unknown Phase 4 DMC

• 1 other identifier: CentroHLOBreastUnit
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormone Dependent Neoplasms; Breast Cancer Female

Keywords

Aromatase inhibitors; Luminal Breast Cancer neoadjuvant hormone therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Tumor Pathology response

  6 weeks

• Disease free survival

  1 5 and 10 years

• Hormone treatment

  1 5 and 10 years

Other Outcomes (1)

• Surgical outome

  3 days 1 month and 3 months

Study Arms (4)

Aromatase Inhibitor group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Aromatase Inhibitor Active surveillance

OTHER

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 Active surveillance + aas

OTHER

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

Interventions

Aromatase Inhibitors DRUG

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

Also known as: Aromatase Inhibitor

Aromatase Inhibitor Active surveillance; Aromatase Inhibitor Active surveillance + aas; Aromatase Inhibitor group

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: female sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• informed consent
• \<50 y.o.
• Pre-menopausal state

Sponsors & Collaborators

• Centro Hospitalar Lisboa Ocidental: lead

Study Sites (1)

Hospital São Francisco Xavier

Lisbon, Portugal

Location

MeSH Terms

Conditions

Neoplasms, Hormone-Dependent

Interventions

Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Vasco Fonseca, MD

  CHLO Medical Oncology dpt

  PRINCIPAL INVESTIGATOR

• Zacharoula Sidiropoulou

  CHLO Surgery dpt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasco Fonseca, MD

CONTACT

0035121 043 1000; medicinavf@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

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

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: April 13, 2017
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: December 5, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)