Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-25 @ 1:41 PM
Study NCT ID:
NCT05472792
Status:
RECRUITING
Last Update Posted:
2025-05-23
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'C056516', 'term': 'exemestane'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D000077267', 'term': 'Fulvestrant'}, {'id': 'D017312', 'term': 'Toremifene'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2032-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Endocrine therapy adherence', 'timeFrame': '5 years', 'description': 'To measure the adherence to the planned endocrine therapy in the endocrine therapy alone arm using a medication usage questionnaire'}, {'measure': 'Disease-free survival', 'timeFrame': '5 years', 'description': 'To assess 5-year DFS-DCIS in subjects who have received accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery.'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'To assess 5-year OS in subjects who receive accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery.'}], 'primaryOutcomes': [{'measure': 'Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Patient reported outcomes assessed by EORTC QLQ-BR45', 'timeFrame': '1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '2 years', 'description': 'To assess the 2-year outcome of disease-free survival, including DCIS (DFS-DCIS), in subjects who have received accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery'}, {'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'To assess the 2-year overall survival (OS) in subjects who have received accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Radiation Therapy', 'Endocrine Therapy', 'Partial Breast Irradiation', 'Elderly', 'Health Related Quality of Life', 'Patient Reported Outcomes'], 'conditions': ['Breast Cancer', 'Quality of Life']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://unclineberger.org/patientcare/clinical-trials/clinical-trials', 'label': 'Clinical trials at UNC Lineberger'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n2. Women greater than or equal to age 65 years with de novo invasive carcinoma of breast.\n3. Pathological T1 (pT1) stage\n4. Estrogen receptor (ER)/ Progesterone receptor (PR) positive (greater than or equal to 10% ER and PR by immunohistochemistry \\[IHC\\] staining)\n5. 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\\])\n6. Grade 1 or 2 overall tumor grade\n7. Clinical or pathological N0\n8. No lymphovascular space invasion (LVSI)\n9. Final surgical margins ≥ 2 mm as per APBI criteria\n10. Subjects with completed breast conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).\n11. Suitable for APBI as deemed by the treating radiation oncologist\n12. 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.\n13. Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial\n\nExclusion Criteria:\n\n1. Pre- or post-operative systemic chemotherapy while on this study.\n2. 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.\n3. Hormonal replacement therapy (eligible if discontinued within 30 days of randomization).\n4. Multifocal or multicentric tumor.\n5. Receipt of tissue rearrangement in the lumpectomy cavity.\n6. Synchronous bilateral breast cancer.\n7. Clinical or imaging evidence of distant metastases.\n8. Prior breast or thoracic radiation.\n9. Autoimmune conditions with associated radiation risks.\n10. Subjects with poor medical risk due to uncontrolled medical conditions that would deem them ineligible for hormonal or radiation therapy.'}, 'identificationModule': {'nctId': 'NCT05472792', 'acronym': 'CAMERAN', 'briefTitle': 'Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Comparison of Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN)', 'orgStudyIdInfo': {'id': 'LCCC2104-DCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endocrine Therapy', 'description': 'Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient.', 'interventionNames': ['Drug: tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene']}, {'type': 'EXPERIMENTAL', 'label': 'Accelerated Partial Breast Irradiation (APBI)', 'description': 'APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity.', 'interventionNames': ['Radiation: Accelerated Partial Breast Irradiation (APBI)']}], 'interventions': [{'name': 'Accelerated Partial Breast Irradiation (APBI)', 'type': 'RADIATION', 'description': 'Radiation treatment delivered to the lumpectomy cavity.', 'armGroupLabels': ['Accelerated Partial Breast Irradiation (APBI)']}, {'name': 'tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene', 'type': 'DRUG', 'description': 'Adjuvant endocrine therapy (tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene) for duration of 5 years, as tolerated by the patient.', 'armGroupLabels': ['Endocrine Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dana Casey, MD', 'role': 'CONTACT', 'email': 'dana_casey@med.unc.edu', 'phone': '984-974-0400'}], 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'centralContacts': [{'name': 'Lori Stravers', 'role': 'CONTACT', 'email': 'lori_stravers@med.unc.edu', 'phone': '+1 919-966-4432'}, {'name': 'Jessica Buddenbaum', 'role': 'CONTACT', 'email': 'jessica_buddenbaum@med.unc.edu', 'phone': '919-966-4432'}], 'overallOfficials': [{'name': 'Dana Casey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}