MedTrace Logo

Investigating Atezolizumab in Newly Diagnosed ER Positive Breast Cancer Patients According to Their AdipOsity

NCT04630210 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2022-06-15

No results posted yet for this study

Summary

One out of 8 women will develop breast cancer (BC) in her lifetime and despite improvements in therapeutic strategies it remains one of the main causes of cancer-related mortality for women in industrialized countries. Over the past decades another worldwide health problem has emerged: obesity. Around 50% of European women are either overweight or obese (body mass index (BMI)≥25 kg/m2: overweight; BMI≥30 kg/m2: obese). The global health effects of high BMI include the well-known elevated risk for developing cardiovascular disease and diabetes and a broad range of cancers, including in the breast.

The connection between BC and obesity is gaining attention because of its clinical relevance. Heavier BC patients are generally older and tend to present with more aggressive disease (larger tumours and more frequent axillary lymph node dissemination). Likewise, they are also at higher risk of recurrence and resistance to therapy. This is of high importance, as development of therapy-resistant metastases is the ultimate cause of death in relapsing patients. Several molecular pathways linking the more aggressive BC nature to obesity have been proposed, such as oestrogens and fat cell signalling molecules, insulin signalling, metabolic inflammation and altered lipid metabolism.

Adiposity is hardly taken into consideration in the treatment of BC patients. This is in contrast with the emerging trend to develop personalized therapies based on individual characteristics of the patient and molecular features of the tumour. Very recent data show that the upcoming treatment strategy of immunotherapy (IT) has better outcomes in obese patients in melanoma, renal cell and lung carcinoma. This could be explained by the fact that obesity induces T-cell dysregulation, which makes these patients more sensitive to IT. Whether or not this accounts for BC as well, is currently unknown. In endocrine BC treatment, research on the effect of BMI on treatment resistance is mainly retrospective and it is unclear whether heavier patients would present a differential benefit to aromatase inhibitors compared to lean patients. Also, most of these studies only considered BMI and no additional adiposity-related inflammation and other variables.

Here, we therefore want to prospectively evaluate the local and systemic effects of aromatase inhibition and immunotherapy, either combined or alone, in a window of opportunity study carried out in luminal B like postmenopausal BC patients.

Conditions

Interventions

DRUG

Letrozole

Letrozole 2.5 mg/day oral until surgery

DRUG

Atezolizumab

Atezolizumab 840 mg intravenous (IV) single-dose 14 days (+/- 4 days) before surgery

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Hans Wildiers, MD PhD · UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2025-01-31
Completion
2025-01-31

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630210 on ClinicalTrials.gov