Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT00290732
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2006-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], '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'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506643', 'term': 'liposomal doxorubicin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vstearn1@jhmi.edu', 'phone': '4432876489', 'title': 'Dr. Vered Stearns', 'organization': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Duct cannulation was not successful in all participants; possibly due to extensive disease or prior excisional biopsy (2 subjects).'}}, 'adverseEventsModule': {'timeFrame': 'After definitive surgery', 'description': 'Note: Adverse events were not collected in the intravenous group/arm; only the concentration of doxorubicin in tissue applied to this group of participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Intraductal Arm- 0 mg PLD', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intraductal Arm- 2 mg PLD', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Intraductal Arm- 5 mg PLD', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Intraductal Arm- 10 mg PLD', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Intravenous Arm', 'description': 'Note: Adverse events were not collected in the intravenous group/arm; only the concentration of doxorubicin in tissue applied to this group of participants.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Breast fullness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Breast or nipple pain/discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Dermatology other (right areolar eschar)', 'notes': 'Eschar/necrosis in the region of the remaining areola of the right breast post-mastectomy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraductal Arm', 'description': 'Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until up to 30 days after PLD administration', 'description': 'Maximum tolerated dose (MTD) of administering pegylated liposomal doxorubicin (PLD) into one duct of women with breast cancer awaiting mastectomy. MTD reflects highest dose of drug that did not cause Dose Limiting Toxicity (DLT) in more than 30% of patients.', 'unitOfMeasure': 'milligrams', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Doxorubicin in Blood (Plasma) at Definitive Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraductal Arm- 0 mg PLD', 'description': 'Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.'}, {'id': 'OG001', 'title': 'Intraductal Arm- 2 mg PLD', 'description': 'Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.'}, {'id': 'OG002', 'title': 'Intraductal Arm- 5 mg PLD', 'description': 'Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.'}, {'id': 'OG003', 'title': 'Intraductal Arm- 10 mg PLD', 'description': 'Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.'}, {'id': 'OG004', 'title': 'Intravenous Arm', 'description': 'Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.'}], 'classes': [{'title': 'Doxorubicin, max', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '28.5', 'groupId': 'OG001'}, {'value': '18.3', 'groupId': 'OG002'}, {'value': '902.0', 'groupId': 'OG003'}, {'value': '79300', 'groupId': 'OG004'}]}]}, {'title': 'Doxorubicinol, max', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36.9', 'groupId': 'OG003'}, {'value': '8090', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 4 hrs, day2/24 hrs, day 8, day of surgery/biopsy', 'description': 'Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in blood (plasma) across all the participants in each group is reported.', 'unitOfMeasure': 'nM', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Doxorubicin in Tissue at Definitive Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraductal Arm- 0 mg PLD', 'description': 'Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.'}, {'id': 'OG001', 'title': 'Intraductal Arm- 2 mg PLD', 'description': 'Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.'}, {'id': 'OG002', 'title': 'Intraductal Arm- 5 mg PLD', 'description': 'Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.'}, {'id': 'OG003', 'title': 'Intraductal Arm- 10 mg PLD', 'description': 'Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.'}, {'id': 'OG004', 'title': 'Intravenous Arm', 'description': 'Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.'}], 'classes': [{'title': 'Doxorubicin, max', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.73', 'groupId': 'OG002'}, {'value': '10.82', 'groupId': 'OG003'}, {'value': '0.21', 'groupId': 'OG004'}]}]}, {'title': 'Doxorubicinol, max', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.09', 'groupId': 'OG002'}, {'value': '5.26', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of surgery/biopsy', 'description': 'Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in tissue across all the participants in each group is reported.', 'unitOfMeasure': 'nmol/g', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intraductal Arm- 0 mg PLD', 'description': 'Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.'}, {'id': 'FG001', 'title': 'Intraductal Arm- 2 mg PLD', 'description': 'Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.'}, {'id': 'FG002', 'title': 'Intraductal Arm- 5 mg PLD', 'description': 'Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.'}, {'id': 'FG003', 'title': 'Intraductal Arm- 10 mg PLD', 'description': 'Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.'}, {'id': 'FG004', 'title': 'Intravenous Arm', 'description': 'Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Inability to instill drug intraductally.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From February 2006 to October 2009, 19 women signed consent, and 17 women were enrolled in the intraductal portion of the study. An addition 3 women receiving standard intravenous PLD were enrolled in a pharmacokinetic contract portion.', 'preAssignmentDetails': 'Participants were not included after consent if eligibility criteria were not met (eg, lab values, performance status); an additional 2 subjects were consented but not included in the study population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intraductal Arm', 'description': 'Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.'}, {'id': 'BG001', 'title': 'Intravenous Arm', 'description': 'Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-07', 'studyFirstSubmitDate': '2006-02-09', 'resultsFirstSubmitDate': '2013-03-01', 'studyFirstSubmitQcDate': '2006-02-09', 'lastUpdatePostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-17', 'studyFirstPostDateStruct': {'date': '2006-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'Until up to 30 days after PLD administration', 'description': 'Maximum tolerated dose (MTD) of administering pegylated liposomal doxorubicin (PLD) into one duct of women with breast cancer awaiting mastectomy. MTD reflects highest dose of drug that did not cause Dose Limiting Toxicity (DLT) in more than 30% of patients.'}], 'secondaryOutcomes': [{'measure': 'Concentrations of Doxorubicin in Blood (Plasma) at Definitive Surgery', 'timeFrame': 'Baseline, 4 hrs, day2/24 hrs, day 8, day of surgery/biopsy', 'description': 'Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in blood (plasma) across all the participants in each group is reported.'}, {'measure': 'Concentrations of Doxorubicin in Tissue at Definitive Surgery', 'timeFrame': 'Day of surgery/biopsy', 'description': 'Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in tissue across all the participants in each group is reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIC breast cancer', 'stage IV breast cancer', 'breast cancer in situ', 'ductal breast carcinoma in situ'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '22030751', 'type': 'RESULT', 'citation': 'Stearns V, Mori T, Jacobs LK, Khouri NF, Gabrielson E, Yoshida T, Kominsky SL, Huso DL, Jeter S, Powers P, Tarpinian K, Brown RJ, Lange JR, Rudek MA, Zhang Z, Tsangaris TN, Sukumar S. Preclinical and clinical evaluation of intraductally administered agents in early breast cancer. Sci Transl Med. 2011 Oct 26;3(106):106ra108. doi: 10.1126/scitranslmed.3002368.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy in different ways, such as into the breast ducts, may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of liposomal doxorubicin when given before mastectomy in treating women with invasive breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate the feasibility, safety, and maximum tolerated dose of intraductal pegylated doxorubicin HCl liposome in women with invasive breast cancer awaiting mastectomy.\n\nSecondary\n\n* Determine the pharmacokinetics of intraductal pegylated doxorubicin HCl liposome, including serial plasma concentrations of doxorubicin and doxorubicinol and tissue concentrations in different portions of the breast at the time of surgery.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive an intraductal injection of pegylated doxorubicin HCl liposome\\* on day 1. Patients undergo mastectomy 2-4 weeks later.\n\nCohorts of 3-6 patients receive escalating doses of pegylated doxorubicin HCl liposome\\* until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.\n\nNOTE: \\*The first cohort of 3 patients receive intraductal dextrose only followed by surgery as a feasibility study. An additional 3 patients receiving intravenous PLD will be enrolled in a pharmacokinetic control portion of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed infiltrating carcinoma of the breast meeting any of the following criteria:\n\n * T1-3, any N disease\n * Proven ductal carcinoma in situ\n* Unresected disease\n\n * Planned mastectomy as definitive surgical procedure\n\n * Known or suspected metastatic disease allowed provided mastectomy is planned\n* Nonpalpable tumor allowed (e.g., initial T2-3 tumor that responded to preoperative therapy)\n* No inflammatory breast cancer or other T4 features\n* Successful baseline ductogram\n\n * Baseline nipple aspiration procedure must identify a duct productive of nipple aspirate fluid\n * No severe nipple retraction\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Female patients\n* Menopausal status not specified\n* ECOG performance status 0-2\n* Absolute neutrophil count ≥1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 9.0 g/dL\n* Creatinine ≤ 2 times upper limit of normal (ULN)\n* Bilirubin ≤ 2 times ULN\n* AST and ALT ≤ 2.5 times ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No significant history of severe allergy to iodinated contrast material or debilitating anxiety that may not allow for a ductogram\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Prior preoperative chemotherapy, trastuzumab (Herceptin®), or hormonal therapy allowed provided it was completed 7-14 days prior to study treatment\n* No prior radiation therapy, excisional biopsy, breast reduction, areolar surgery, or breast implant (present or past history of implant that was removed)\n* No other prior procedure that may have altered the breast ductal system in the ipsilateral breast\n* No other concurrent chemotherapy, radiotherapy, endocrine therapy, or biologic agents for breast cancer\n* No other concurrent investigational drugs\n* Concurrent bisphosphonates allowed'}, 'identificationModule': {'nctId': 'NCT00290732', 'briefTitle': 'Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'A Phase I Study Assessing the Feasibility and Safety of Intraductal Administration of Pegylated Liposomal Doxorubicin (Doxil) in Women With Breast Cancer', 'orgStudyIdInfo': {'id': 'J0503 CDR0000459502'}, 'secondaryIdInfos': [{'id': 'P30CA006973', 'link': 'https://reporter.nih.gov/quickSearch/P30CA006973', 'type': 'NIH'}, {'id': 'JHOC-J0503', 'type': 'OTHER', 'domain': 'SKCCC at Johns Hopkins'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraductal arm', 'description': 'Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.', 'interventionNames': ['Drug: Intraductal arm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous arm', 'description': 'Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.', 'interventionNames': ['Drug: Intravenous arm']}], 'interventions': [{'name': 'Intraductal arm', 'type': 'DRUG', 'otherNames': ['Doxorubicin HCl Liposome Injection, Dox-SL, Doxil TM'], 'description': 'Patients will receive PLD intraductally according to the dose escalation schema (Dose Level -1=1 mg, Dose Level 1=2 mg, Dose Level 2= 5mg, Dose Level 3=10 mg). The PLD dose will be diluted in 5% dextrose in water and will be mixed for a total volume of 5 ml. The PLD will be administered via a breast duct (i.e., intraductally) using a microcatheter', 'armGroupLabels': ['Intraductal arm']}, {'name': 'Intravenous arm', 'type': 'DRUG', 'otherNames': ['Doxorubicin HCl Liposome Injection, Dox-SL, Doxil TM'], 'description': 'Blood samples and a breast tissue biopsy collected to look at levels of doxorubincol from patients receiving intravenous pegylated liposomal doxorubin to compare to the group receiving drug intraductally.', 'armGroupLabels': ['Intravenous arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202-5289', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21231-2410', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Vered Stearns, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}