Clinical Trials /

Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer

NCT03238703

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Withdrawn

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer
  • Official Title: An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)

Clinical Trial IDs

  • ORG STUDY ID: 9764
  • SECONDARY ID: NCI-2017-00724
  • SECONDARY ID: 9764
  • SECONDARY ID: P30CA015704
  • NCT ID: NCT03238703

Conditions

  • HER2/Neu Negative
  • Invasive Breast Carcinoma
  • Postmenopausal
  • Stage 0 Breast Cancer
  • Stage IA Breast Cancer

Interventions

DrugSynonymsArms
AnastrozoleAnastrazole, Arimidex, ICI D1033, ICI-D1033, ZD-1033Treatment (AI, SERM)
ExemestaneAromasin, FCE-24304Treatment (AI, SERM)
LetrozoleCGS 20267, FemaraTreatment (AI, SERM)
Tamoxifen CitrateApo-Tamox, Clonoxifen, Dignotamoxi, Ebefen, Emblon, Estroxyn, Fentamox, Gen-Tamoxifen, Genox, ICI 46,474, ICI-46474, Jenoxifen, Kessar, Ledertam, Lesporene, Nolgen, Noltam, Nolvadex, Nolvadex-D, Nourytam, Novo-Tamoxifen, Novofen, Noxitem, Oestrifen, Oncotam, PMS-Tamoxifen, Soltamox, TAM, Tamax, Tamaxin, Tamifen, Tamizam, Tamofen, Tamoxasta, Tamoxifeni Citras, ZemideTreatment (AI, SERM)
Toremifene CitrateAcapodene, Fareston, FC-1157a, GTx-006Treatment (AI, SERM)

Purpose

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.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To estimate the conversion rate from a standard low-toxicity approach to
      guideline-directed therapy which includes surgery +/- radiation therapy as a result of
      progression of disease or patient/provider choice.

      II. To examine factors that might differ between those who convert from the low-toxicity
      approach to the guideline-directed therapy and those do not convert.

      SECONDARY OBJECTIVES:

      I. To measure the safety and clinical effectiveness of systemic endocrine therapy used in a
      prolonged neoadjuvant fashion.

      II. To evaluate the impact of risk-stratified care in Quality-Adjusted Life Years (QALY) and
      QALY gains.

      III. To estimate the cost savings of indefinitely delaying surgery and radiation in favor of
      systemic endocrine therapy alone.

      OUTLINE:

      Patients receive exemestane orally (PO) once daily (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.

      After completion of study treatment, patients are followed up periodically.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (AI, SERM)ExperimentalPatients 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.
  • Anastrozole
  • Exemestane
  • Letrozole
  • Tamoxifen Citrate
  • Toremifene Citrate

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:60 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Conversion from oral endocrine therapy for any reason to guideline-directed therapy
Time Frame:Up to 5 years
Safety Issue:
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).

Secondary Outcome Measures

Measure:Advanced imaging (if performed on any subset of patients)
Time Frame:Up to 5 years
Safety Issue:
Description:Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/‐ radiation therapy followed by systemic endocrine therapy. 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).
Measure:Cost-effectiveness and patient-centeredness outcomes defined as financial toxicity and solubility, quality of life (physical, mental, emotional changes) on endocrine therapy, and, access to support services
Time Frame:Up to 5 years
Safety Issue:
Description:Comparisons will be made to historical benchmarks for similar patients managed in a conventional locoregional manner for early‐stage breast cancer. 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).
Measure:Effect of age
Time Frame:Up to 5 years
Safety Issue:
Description:Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/‐ radiation therapy followed by systemic endocrine therapy. 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).
Measure:Effect of comorbidity severity interaction
Time Frame:Up to 5 years
Safety Issue:
Description:Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/‐ radiation therapy followed by systemic endocrine therapy. 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).
Measure:Effect of type of endocrine therapy type (selective estrogen receptor modifier versus aromatase inhibitor)
Time Frame:Up to 5 years
Safety Issue:
Description:Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/‐ radiation therapy followed by systemic endocrine therapy. 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).
Measure:Effects emanating from tertiary care
Time Frame:Up to 5 years
Safety Issue:
Description:Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/‐ radiation therapy followed by systemic endocrine therapy. 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).
Measure:Progression of disease while on primary endocrine therapy, as measured objectively by routine diagnostic breast imaging (mammography and/or ultrasound)
Time Frame:Up to 5 years
Safety Issue:
Description: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).

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Fred Hutchinson Cancer Research Center

Last Updated

October 13, 2017