Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer

NCT03917082 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: LA LEAST
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial of 2 years of standard adjuvant endocrine therapy after low risk hormone receptor positive, HER2 negative, node negative breast cancer in women older than 50 at diagnosis. The study hypothesis is that reducing adjuvant endocrine therapy from 5 to 2 years in a population with low risk of breast cancer; as determined by histopathologic criteria and confirmed by low risk genomic analysis using Prosigna®; will be safe and acceptable to this population, and will not compromise the expected excellent breast cancer specific outcomes for this population.

Conditions

Breast Cancer Female; Hormone Receptor Positive Tumor

Keywords

endocrine therapy

Outcome Measures

Primary Outcomes (1)

• Distant Relapse Free Interval at five years

  freedom from distant recurrence or breast cancer death at 5 years

  5 years after the last patient is enrolled

Secondary Outcomes (2)

• Ten year breast cancer free interval

  ten years after the last patient is enrolled

• Ten year contralateral breast cancer incidence

  ten years after the last patient is enrolled

Study Arms (1)

standard of care endocrine therapy for two years

EXPERIMENTAL

Standard of care adjuvant endocrine therapy for two years. for postmenopausal women, initial therapy will be aromatase inhibitor unless contraindicated, in which case tamoxifen may be used. For premenopausal and perimenopausal women, initial therapy will be tamoxifen unless contraindicated, in which case an lutenizing hormone releasing hormone (LHRH) agonist with / without aromatase inhibitor may be used.

Drug: Tamoxifen Citrate

Interventions

Tamoxifen Citrate DRUG

current standard of care is 5 years endocrine therapy after early breast cancer. Intervention will test if 2 years is adequate for population with low recurrence risk based on genomic tissue based test

Also known as: aromatase inhibitor

standard of care endocrine therapy for two years

Eligibility Criteria

• Age: 51 Years+
• Gender Eligibility Details: breast cancer incidence ratio in women vs men is 10:1. Given the sample size of the study, it is unlikely that enrolling men will provide any meaningful data about the impact of limited endocrine therapy for male breast cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of invasive breast cancer which is:
• Unifocal or multifocal (not multicentric)
• Unilateral
• Moderate or strongly hormone receptor positive
• HER2 negative
• Ductal grade 1 or 2, or lobular any grade, or pure tubular (any grade) or pure papillary (any grade). If mixed lobular-ductal histology, the ductal component must be grade 1 or 2.
• Stage pT1N0 (tumor \</= 20mm, negative node) or pT2N0 (tumor 21-50mm, node negative) or pT1N0i+ (tumor \</=20mm and isolated tumor cells in node\[s\]) or pT2N0i+ (tumor 21-50mm and isolated tumor cells in node\[s\]) (see Appendix 2). Tumor size must be sufficient for Prosigna® testing. pNX (nodal status unknown) stage is not eligible.
• Subject must be female
• Subject must be age \> 50 years at breast cancer diagnosis
• Subject may be pre, peri, or postmenopausal.
• Subject must have a \> 5-year life expectancy based on physician judgement of subject's co-morbid illnesses and age
• Subject must undergo standard of care loco-regional management (sentinel node biopsy and/or axillary dissection; breast conserving surgery or mastectomy; radiation to breast following breast conserving surgery, with radiotherapy details per local institution practice). Surgery will have been no more than 24 weeks prior to endocrine therapy start. Subjects having repeat surgeries after radiation, regardless of indication, should count the date of last surgery that preceded radiation. Subjects may undergo Prosigna® screening prior to completion of radiation.
• The breast surgery will have achieved negative surgical margins. Tumours with positive margins that are not re-resectable are eligible if followed by radiation with a boost (partial mastectomy) or chest wall radiation (mastectomy)
• No (neoadjuvant or adjuvant) chemotherapy given or planned for this breast cancer
• No other non-breast cancer within the last 5 years, except non-melanoma skin cancer, melanoma in situ, cervix carcinoma in situ, and anal carcinoma in situ

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Canadian Cancer Society (CCS): collaborator
• NanoString Technologies, Inc.: collaborator

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z4E6, Canada

Location

Related Publications (55)

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• Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.

  PMID: 8844630 BACKGROUND

MeSH Terms

Interventions

Tamoxifen; Aromatase Inhibitors

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 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

• Caroline Lohrisch, MC

  BC Cancer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist, Department head, medical oncology Vancouver Centre

Model Details: Single arm phase II study exploring reducing the duration of endocrine therapy from five to two years in low risk population with early breast cancer

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: April 16, 2019
• Study Start: September 23, 2019
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)