Clinical trial · Interventional
Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer
An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)
NCT03238703CI-TRIAL-00036283withdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administrative closure based on sponsor recommendation, prior to subject enrollment
Summary
Brief summary (as posted)
This pilot clinical trial studies how well endocrine therapy works in treating patients with HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells. Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators may lessen the amount of estrogen made by the body.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2/Neu Negative | — | UNRESOLVED | — |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Postmenopausal | — | UNRESOLVED | — |
| Stage 0 Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Exemestane | Drug | Exemestane | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Tamoxifen Citrate | Drug | Tamoxifen | ALIAS |
| Toremifene Citrate | Drug | Toremifene | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (AI, SERM)
- description
- Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Anastrozole
- Drug: Exemestane
- Other: Laboratory Biomarker Analysis
- Drug: Letrozole
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Drug: Tamoxifen Citrate
- Drug: Toremifene Citrate
Primary outcomes (1)
- measure
- Conversion from oral endocrine therapy for any reason to guideline-directed therapy
- timeFrame
- Up to 5 years
- description
- Includes clinical or radiographic progression, patient preference, endocrine therapy intolerance or toxicity, or death from any cause. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide written informed consent * A diagnosis of invasive breast cancer, with or without an in situ component, that is: * Originally identified by screening mammography * Characterized by standard diagnostic mammography +/- breast ultrasound * Clinically node negative * Confirmed by breast magnetic resonance imaging (MRI) in a facility that maintains active American College of Radiology (ACR) accreditation to be of low clinical stage (=\< 2 cm, node negative, unifocal invasive) * Estrogen receptor (ER) and progesterone receptor (PR) Allred scored, each \> 5/8 * Her2 negative using American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines * ki-67 proliferation scored, \< 20% * Clinical Nottingham grade 1 or 2 * Scored on the MammaPrint 70-gene breast cancer recurrence assay as low risk * Prior to the discovery of the breast cancer, clinically post-menopausal as defined as: i) one or more years from last menses; or ii) history of oophorectomy; or iii) follicle stimulating hormone (FSH) test result in the post-menopause reference range * Willing to accept oral endocrine therapy with a third generation aromatase inhibitor (AI) or selective estrogen receptor modifier (SERM) * Willing to undergo routine surveillance with breast ultrasound and/or mammography Exclusion Criteria: * Known contraindication to aromatase inhibitor or SERM therapy * Pregnant at time of or within prior year of diagnosis * Clinically detected or palpable disease prior to biopsy in either breast or ipsilateral axilla * Prior history of invasive breast cancer or ductal breast carcinoma in situ (DCIS) * Prior use of aromatase inhibitor therapy apart from assisted reproduction * Prior use of SERM * Unmanaged/uncontrolled mental health disorder * Life expectancy \< 6 months (m) for any cause * Biopsy confirmed multifocal, multicentric, or contralateral disease that is invasive or non-invasive * DCIS with focal invasion
References
Publications (0)
Data not yet available
No reference posted for this study.