Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score

Conditions

• Breast Cancer
• Breast Neoplasms
• Cancer of Breast
• Cancer of the Breast

Eligibility Criteria

Sex

FEMALE

Age

70 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• FACT-B — BEHAVIORAL
  The FACT-B (Version 4) is a 37-item measure that contains the four general subscales along with the Breast Cancer-Specific subscale that assesses symptoms/concerns of particular relevance to breast cancer (e.g., body image, arm swelling and tenderness).
• Goserelin — DRUG
• Anastrozole — DRUG
• Exemestane — DRUG
• Fulvestrant — DRUG
• Tamoxifen — DRUG
• Archived tissue collection — OTHER

Study Details

Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.

Key Dates

Start date

Jan 17, 2017

Status verified

Jul 2025

Primary completion

Jan 31, 2027

Completion

Jul 31, 2032

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Endocrine therapy alone
  * Neoadjuvant endocrine therapy will be given at the discretion of the treating physician as directed by the package insert and could include the following: goserelin, anastrozole, letrozole, exemestane, fulvestrant, or tamoxifen * Frequency of office visits will be decided by the treating physician but must occur no less frequently than every 3 to 6 months for tumor assessment * After 6 months and after 12 months, patients will be assessed; patients who progress will have standard care recommended , and at any point a patient can opt to receive standard care even if she has not progressed on neoadjuvant endocrine therapy * Information on quality of life will be collected at baseline, Year 1, and Year 2 by the FACT-B questionnaire * Archival tissue will be collected and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score predicts chemotherapy benefit and indicates the 10-year risk of recurrence (will not be used to determine treatment)

Primary Outcome Measure

Response rate [ Time Frame: 6 months ]

Central Contacts

• Rebecca L Aft, M.D., Ph.D.
  314-747-0063
  [email protected]
• Tracie Guthrie
  314-747-4404
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

Related Studies

• Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
  Recruiting · Washington University School of Medicine · St Louis, Missouri
• Integrated Cancer Repository for Cancer Research
  Recruiting · University of Nebraska · Greenwood Village, Colorado
• Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry
  Recruiting · University of Kansas Medical Center · Hays, Kansas
• MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
  Recruiting · Agendia · Birmingham, Alabama