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

• ClinicalTrials.gov Identifier: NCT03111615
• Recruitment Status: Unknown
• First Posted: April 13, 2017
• Last Update Posted: December 5, 2017
• Sponsor: Centro Hospitalar Lisboa Ocidental
• Information provided by (Responsible Party): Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental

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
Hormone Dependent Neoplasms; Breast Cancer Female	Drug: Aromatase Inhibitors	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:

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• 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
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Hormone Therapy Initiation Immediately After Histological Diagnosis of Breast Cancer, Can it Make Any Difference?
• Estimated Study Start Date: May 1, 2018
• Estimated Primary Completion Date: May 1, 2019
• Estimated Study Completion Date: May 1, 2020

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 Name: 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))
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 Name: Aromatase Inhibitor
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 Name: Aromatase Inhibitor

Outcome Measures

Primary Outcome Measures :

1. Tumor Biology [ Time Frame: 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 :

1. Tumor Pathology response [ Time Frame: 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
2. Disease free survival [ Time Frame: 1 5 and 10 years ]
   Effects of neoadjuvant aromatase inibitors on disease free survival the first, fifth and tenth years of follow-up
3. Hormone treatment [ Time Frame: 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:

1. Surgical outome [ Time Frame: 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

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: female sex
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Vasco Fonseca, MD; 0035121 043 1000; medicinavf@yahoo.com

Locations

Portugal

Hospital São Francisco Xavier

Lisbon, Portugal

Sub-Investigator: Margarida Brito, MD

Sponsors and Collaborators

Centro Hospitalar Lisboa Ocidental

Investigators

• Principal Investigator: Vasco Fonseca, MD; CHLO Medical Oncology dpt
• Principal Investigator: Zacharoula Sidiropoulou; CHLO Surgery dpt

More Information

• Responsible Party: Zacharoula Sidiropoulou, Principal investigator, Centro Hospitalar Lisboa Ocidental
• ClinicalTrials.gov Identifier: NCT03111615
• Other Study ID Numbers: CentroHLOBreastUnit
• First Posted: April 13, 2017
• Last Update Posted: December 5, 2017
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental:

Aromatase inhibitors; Luminal Breast Cancer neoadjuvant hormone therapy

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms, Hormone-Dependent; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs