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Compares treatment options for Breast Cancer
Official title Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy
ClinicalTrials.gov ID: NCT05472792
What this study is testing
What is tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene?
tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older, women only
You may be able to join if
- Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health...
- 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)...
You likely can't join 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...
- 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.
See the full eligibility criteria
- 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...
- 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
- people 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
- people with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial
- 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.
- people with poor medical risk due to uncontrolled medical conditions that would deem them ineligible for hormonal or radiation therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.