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RecruitingPhase 2

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

Comparison of Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares radiation to part of the breast with hormone-blocking medicine after surgery to remove a breast lump (lumpectomy). It is for women age 65 or older with low-risk breast cancer. Researchers will compare quality of life and how well each treatment controls cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 65 or older with newly diagnosed invasive breast cancer, meaning cancer that has grown into nearby breast tissue.
  • The tumor must be stage pT1 and grade 1 or 2, meaning the cancer cells look less abnormal under a microscope.
  • At least 10% of tumor cells must test positive for each hormone receptor, ER and PR. The tumor must be HER2-negative.
  • No cancer found in lymph nodes or in small blood vessels or lymph vessels.
  • Completed breast-saving surgery, with or without lymph node surgery. The removed tissue must have a cancer-free edge at least 2 millimeters wide.
  • A radiation doctor must decide that radiation to part of the breast is suitable.
  • Able and willing to sign a consent form and allow the use of personal health information.
  • Other cancers or enrollment in another study are allowed only if they do not interfere with this study's treatment or safety checks.

Who can't join

  • Chemotherapy before or after surgery while taking part in this study.
  • Ongoing hormone-blocking medicine or hormone replacement therapy, unless stopped within 30 days of assignment to a study group.
  • Cancer in more than one area of the breast, or cancer in both breasts at the same time.
  • Breast tissue was moved around within the area where the lump was removed.
  • Signs on an exam or scan that cancer has spread to distant parts of the body.
  • Past radiation to the breast or chest.
  • An autoimmune disease, in which the immune system attacks the body, that raises radiation risks.
  • Uncontrolled health problems that make hormone treatment or radiation unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. 2. Women greater than or equal to age 65 years with de novo invasive carcinoma of breast. 3. Pathological T1 (pT1) stage 4. Estrogen receptor (ER)/ Progesterone receptor (PR) positive (greater than or equal to 10% ER and PR by immunohistochemistry \[IHC\] staining) 5. 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 \[ISH\]) 6. Grade 1 or 2 overall tumor grade 7. Clinical or pathological N0 8. No lymphovascular space invasion (LVSI) 9. Final surgical margins ≥ 2 mm as per APBI criteria 10. Subjects with completed breast conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). 11. Suitable for APBI as deemed by the treating radiation oncologist 12. 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. 13. Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial Exclusion Criteria: 1. Pre- or post-operative systemic chemotherapy while on this study. 2. 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. 3. Hormonal replacement therapy (eligible if discontinued within 30 days of randomization). 4. Multifocal or multicentric tumor. 5. Receipt of tissue rearrangement in the lumpectomy cavity. 6. Synchronous bilateral breast cancer. 7. Clinical or imaging evidence of distant metastases. 8. Prior breast or thoracic radiation. 9. Autoimmune conditions with associated radiation risks. 10. Subjects with poor medical risk due to uncontrolled medical conditions that would deem them ineligible for hormonal or radiation therapy.

Study sites (1)

NC