Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy

NCT05472792 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: LCCC2104-DCT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective study is to investigate quality of life and oncologic outcomes in low-risk elderly breast cancer patients randomized to adjuvant therapy with accelerated partial breast irradiation (APBI) alone or endocrine therapy alone after lumpectomy. The study population will include women age 65 years and older with low-risk tumor characteristics (tumor size \<2cm, grade 1-2, node-negative). APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity. Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient. Quality of life outcomes will be measured at 1 year following lumpectomy and compared between groups. We hypothesize that the use of APBI may be superior in terms of quality of life when compared to endocrine therapy alone following lumpectomy while providing equivalent rates of disease control and overall survival. In this phase II study, we anticipate enrolling 90 women at N.C. Cancer Hospital in Chapel Hill, NC.

Conditions

Breast Cancer; Quality of Life

Keywords

Radiation Therapy; Endocrine Therapy; Partial Breast Irradiation; Elderly; Health Related Quality of Life; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (2)

• Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30

  To compare quality of life at 1 year after breast conserving surgery in those who receive adjuvant accelerated partial breast irradiation alone versus adjuvant endocrine therapy alone as measured by the EORTC QLQ-C30. Raw scores are linearly converted to a 0-100 scale with higher symptom scales reflecting increased levels of symptom burden.

  1 year

• Patient reported outcomes assessed by EORTC QLQ-BR45

  To compare quality of life at 1 year after breast conserving surgery in those who receive adjuvant accelerated partial breast irradiation alone versus adjuvant endocrine therapy alone as measured by the EORTC QLQ-BR45. Raw scores are linearly converted to a 0-100 scale with higher symptom scales reflecting increased levels of symptom burden.

  1 year

Secondary Outcomes (2)

• Disease-free survival

  2 years

• Overall survival

  2 years

Other Outcomes (3)

• Endocrine therapy adherence

  5 years

• Disease-free survival

  5 years

• Overall survival

  5 years

Study Arms (2)

Endocrine Therapy

ACTIVE COMPARATOR

Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient.

Drug: tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene

Accelerated Partial Breast Irradiation (APBI)

EXPERIMENTAL

APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity.

Radiation: Accelerated Partial Breast Irradiation (APBI)

Interventions

Accelerated Partial Breast Irradiation (APBI) RADIATION

Radiation treatment delivered to the lumpectomy cavity.

Accelerated Partial Breast Irradiation (APBI)

tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene DRUG

Adjuvant endocrine therapy (tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene) for duration of 5 years, as tolerated by the patient.

Endocrine Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• Women greater than or equal to age 65 years with de novo invasive carcinoma of breast.
• Pathological T1 (pT1) stage
• Estrogen receptor (ER)/ Progesterone receptor (PR) positive (greater than or equal to 10% ER and PR by immunohistochemistry \[IHC\] staining)
• Human epidermal growth factor receptor 2 (HER2) - according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines (0 or 1+ following IHC staining or proven negative by in-situ hybridization \[ISH\])
• Grade 1 or 2 overall tumor grade
• Clinical or pathological N0
• No lymphovascular space invasion (LVSI)
• Final surgical margins ≥ 2 mm as per APBI criteria
• Subjects with completed breast conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
• Suitable for APBI as deemed by the treating radiation oncologist
• Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial

You may not qualify if:

• Pre- or post-operative systemic chemotherapy while on this study.
• Current ongoing treatment with anti-hormonal agents. If previously on anti-hormonal agents and planning to stop, the subject must discontinue within 30 days of randomization.
• Hormonal replacement therapy (eligible if discontinued within 30 days of randomization).
• Multifocal or multicentric tumor.
• Receipt of tissue rearrangement in the lumpectomy cavity.
• Synchronous bilateral breast cancer.
• Clinical or imaging evidence of distant metastases.
• Prior breast or thoracic radiation.
• Autoimmune conditions with associated radiation risks.
• Subjects with poor medical risk due to uncontrolled medical conditions that would deem them ineligible for hormonal or radiation therapy.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Anastrozole; exemestane; Letrozole; Fulvestrant; Toremifene

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Dana Casey, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori Stravers

CONTACT

+1 919-966-4432; lori_stravers@med.unc.edu

Jessica Buddenbaum

CONTACT

919-966-4432; jessica_buddenbaum@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 25, 2022
• Study Start: May 17, 2022
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2032
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

US (1)