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Trial record 51 of 2158 for:    doxorubicin

Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer

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ClinicalTrials.gov Identifier: NCT00290732
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : September 26, 2013
Last Update Posted : October 31, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Intraductal arm
Drug: Intravenous arm
Enrollment 20
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Intraductal Arm- 0 mg PLD Intraductal Arm- 2 mg PLD Intraductal Arm- 5 mg PLD Intraductal Arm- 10 mg PLD Intravenous Arm
Hide Arm/Group Description Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer. Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer. Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer. Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer. Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
Period Title: Overall Study
Started 3 4 4 6 3
Completed 3 3 3 6 3
Not Completed 0 1 1 0 0
Reason Not Completed
Inability to instill drug intraductally.             0             1             1             0             0
Arm/Group Title Intraductal Arm Intravenous Arm Total
Hide Arm/Group Description Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer. Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations. Total of all reporting groups
Overall Number of Baseline Participants 17 3 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 3 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  88.2%
3
 100.0%
18
  90.0%
>=65 years
2
  11.8%
0
   0.0%
2
  10.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 3 participants 20 participants
Female
17
 100.0%
3
 100.0%
20
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 3 participants 20 participants
17 3 20
1.Primary Outcome
Title Maximum Tolerated Dose (MTD)
Hide 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.
Time Frame Until up to 30 days after PLD administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
Arm/Group Title Intraductal Arm
Hide Arm/Group Description:
Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: milligrams
10
2.Secondary Outcome
Title Concentrations of Doxorubicin in Blood (Plasma) at Definitive Surgery
Hide 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.
Time Frame Baseline, 4 hrs, day2/24 hrs, day 8, day of surgery/biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.
Arm/Group Title Intraductal Arm- 0 mg PLD Intraductal Arm- 2 mg PLD Intraductal Arm- 5 mg PLD Intraductal Arm- 10 mg PLD Intravenous Arm
Hide Arm/Group Description:
Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
Overall Number of Participants Analyzed 3 3 3 6 3
Measure Type: Number
Unit of Measure: nM
Doxorubicin, max 0 28.5 18.3 902.0 79300
Doxorubicinol, max 0 0 0 36.9 8090
3.Secondary Outcome
Title Concentrations of Doxorubicin in Tissue at Definitive Surgery
Hide 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.
Time Frame Day of surgery/biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.
Arm/Group Title Intraductal Arm- 0 mg PLD Intraductal Arm- 2 mg PLD Intraductal Arm- 5 mg PLD Intraductal Arm- 10 mg PLD Intravenous Arm
Hide Arm/Group Description:
Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
Overall Number of Participants Analyzed 3 3 3 6 3
Measure Type: Number
Unit of Measure: nmol/g
Doxorubicin, max 0 0 1.73 10.82 0.21
Doxorubicinol, max 0 0 0.09 5.26 0
Time Frame After definitive surgery
Adverse Event Reporting 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.
 
Arm/Group Title Intraductal Arm- 0 mg PLD Intraductal Arm- 2 mg PLD Intraductal Arm- 5 mg PLD Intraductal Arm- 10 mg PLD Intravenous Arm
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Note: Adverse events were not collected in the intravenous group/arm; only the concentration of doxorubicin in tissue applied to this group of participants.
All-Cause Mortality
Intraductal Arm- 0 mg PLD Intraductal Arm- 2 mg PLD Intraductal Arm- 5 mg PLD Intraductal Arm- 10 mg PLD Intravenous Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intraductal Arm- 0 mg PLD Intraductal Arm- 2 mg PLD Intraductal Arm- 5 mg PLD Intraductal Arm- 10 mg PLD Intravenous Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      1/6 (16.67%)      0/0    
Skin and subcutaneous tissue disorders           
Dermatology other (right areolar eschar)  1 [1]  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Eschar/necrosis in the region of the remaining areola of the right breast post-mastectomy.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intraductal Arm- 0 mg PLD Intraductal Arm- 2 mg PLD Intraductal Arm- 5 mg PLD Intraductal Arm- 10 mg PLD Intravenous Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      0/0    
Reproductive system and breast disorders           
Breast fullness  1  3/3 (100.00%)  3 3/3 (100.00%)  3 2/3 (66.67%)  2 1/6 (16.67%)  1 0/0  0
Breast or nipple pain/discomfort  1  2/3 (66.67%)  2 3/3 (100.00%)  3 3/3 (100.00%)  3 6/6 (100.00%)  6 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Duct cannulation was not successful in all participants; possibly due to extensive disease or prior excisional biopsy (2 subjects).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Vered Stearns
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 4432876489
EMail: vstearn1@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00290732     History of Changes
Other Study ID Numbers: J0503 CDR0000459502
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0503 ( Other Identifier: SKCCC at Johns Hopkins )
First Submitted: February 9, 2006
First Posted: February 13, 2006
Results First Submitted: March 1, 2013
Results First Posted: September 26, 2013
Last Update Posted: October 31, 2013