A Phase 1 interventional study of DS-8201a in Malignant Neoplasm of Breast, sponsored by Daiichi Sankyo Co., Ltd.. Completed at 7 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.
Sponsored by Daiichi Sankyo Co., Ltd. · Phase 1, Interventional, and Treatment
This study will look at the effect on the QTc interval and pharmacokinetics after multiple dosing in subjects with HER2-expressing metastatic and/or unresectable breast cancer.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 51 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Daiichi Sankyo Co., Ltd. is the lead sponsor of 73 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive DS-8201a by intravenous infusion
Drug: DS-8201a
DS-8201a is supplied as a lyophilized powder which is reconstituted for infusion
Also known as: Experimental product
Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer
The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported.
Time frame: Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days)
Pharmacokinetic Parameters of Maximum Serum Concentration (Cmax) After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer
Maximum serum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed.
Time frame: Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days)
Pharmacokinetic Parameters of Maximum Serum Concentration (Cmax) of MAAA-1181 After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer
Maximum serum concentration (Cmax) of MAAA-1181 was assessed.
Time frame: Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days)
Pharmacokinetic Parameters Area Under the Concentration-Time Curve After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer
Area under the concentration versus-time curve from time 0 to the last quantifiable concentration (AUClast) and during the dosing interval (AUCtau) of DS-8201a and total anti-HER2 antibody were assessed.
Time frame: Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days)
Pharmacokinetic Parameters Area Under the Concentration-Time Curve of MAAA-1181 After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer
Area under the concentration versus-time curve from time 0 to the last quantifiable concentration (AUClast) and during the dosing interval (AUCtau) were assessed.
Time frame: Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days)
Objective Response Rate Based on The Investigator's Assessment (Unconfirmed) Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer
Objective response rate (ORR) was defined as unconfirmed complete response (CR) and partial response (PR) as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 12 months post-dose
Objective Response Rate Based on The Investigator's Assessment (Unconfirmed) Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer
Objective response rate (ORR) was defined as unconfirmed complete response (CR) and partial response (PR) as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 38 months post-dose
Treatment-Emergent Adverse Events of Any Grade by System Organ Classes and Preferred Term Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer
Adverse events (AEs) were to be coded using MedDRA Version 20.1 and assigned severity grades based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiating the study drug until 47 days after last dose of study drug.
Time frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to approximately 12 months post-dose
A total of 51 participants who met all inclusion criteria and no exclusion criteria were enrolled and treated at 7 sites in Japan.
| Milestone | DS-8201a |
|---|---|
| Started | 51 |
| Completed | 0 |
| Not completed | 51 |
| Withdrew: Progressive disease per recist v1.1 | 33 |
| Withdrew: Adverse event | 12 |
| Withdrew: Clinical progression | 2 |
| Withdrew: Withdrawal by subject | 4 |
The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported.
| Participants | DS-8201a |
|---|---|
| Maximum change from baseline in QTcF: >30 ms | 3 |
| Maximum change from baseline in QTcF: >60 ms | 0 |
Maximum serum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed.
| ug/mL | DS-8201a |
|---|---|
| DS-8201: Cycle 1 | 179 ± 112 |
| DS-8201: Cycle 3 | 154 ± 23.3 |
| Total Anti-HER2 antibody: Cycle 1 | 165 ± 110 |
| Total Anti-HER2 antibody: Cycle 3 | 142 ± 27.0 |
Maximum serum concentration (Cmax) of MAAA-1181 was assessed.
| ng/mL | DS-8201a |
|---|---|
| MAAA-1181a: Cycle 1 | 12.6 ± 4.49 |
| MAAA-1181a: Cycle 3 | 9.60 ± 3.89 |
Area under the concentration versus-time curve from time 0 to the last quantifiable concentration (AUClast) and during the dosing interval (AUCtau) of DS-8201a and total anti-HER2 antibody were assessed.
| ug*d/mL | DS-8201a |
|---|---|
| AUClast, DS-8201: Cycle 1 | 677 ± 143 |
| AUClast, Total Anti-HER2 antibody: Cycle 1 | 753 ± 190 |
| AUCtau, DS-8201: Cycle 1 | 677 ± 141 |
| AUCtau, DS-8201: Cycle 3 | 905 ± 189 |
| AUCtau, Total Anti-HER2 antibody: Cycle 1 | 752 ± 185 |
| AUCtau, Total Anti-HER2 antibody: Cycle 3 | 1030 ± 256 |
Area under the concentration versus-time curve from time 0 to the last quantifiable concentration (AUClast) and during the dosing interval (AUCtau) were assessed.
| ng*d/mL | DS-8201a |
|---|---|
| AUClast, MAAA-1181a: Cycle 1 | 39.3 ± 11.3 |
| AUCtau, MAAA-1181a: Cycle 1 | 39.0 ± 11.2 |
| AUCtau, MAAA-1181a: Cycle 3 | 41.5 ± 13.8 |
Objective response rate (ORR) was defined as unconfirmed complete response (CR) and partial response (PR) as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
| Participants | HER2 Positive | HER2 Low |
|---|---|---|
| Objective Response Rate Based on The Investigator's Assessment (Unconfirmed) Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | 2 | 18 |
Objective response rate (ORR) was defined as unconfirmed complete response (CR) and partial response (PR) as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
| Participants | HER2 Positive | HER2 Low |
|---|---|---|
| Objective Response Rate Based on The Investigator's Assessment (Unconfirmed) Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | 2 | 23 |
Adverse events (AEs) were to be coded using MedDRA Version 20.1 and assigned severity grades based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiating the study drug until 47 days after last dose of study drug.
| Participants | DS-8201a |
|---|---|
| Any TEAEs | 51 |
| Gastrointestinal Disorders | 45 |
| Nausea | 42 |
| Vomiting | 20 |
| Constipation | 16 |
| Stomatitis | 16 |
| Diarrhoea | 14 |
| Investigations | 45 |
| Neutrophil count decreased | 36 |
| White blood cell count decreased | 31 |
| Platelet count decreased | 20 |
| Lymphocyte count decreased | 13 |
| Alanine aminotransferase increased | 12 |
| Aspartate aminotransferase increased | 12 |
| Blood and Lymphatic System Disorders | 30 |
| Anaemia | 30 |
| Skin and Subcutaneous Tissue Disorders | 27 |
| Alopecia | 21 |
| General Disorders and Administration Site Conditions | 25 |
| Fatigue | 11 |
| Infections and Infestations | 21 |
| Nasopharyngitis | 11 |
| Metabolism and Nutrition Disorders | 19 |
| Decreased appetite | 16 |
| Nervous System Disorders | 15 |
| Respiratory, Thoracic, and Mediastinal Disorders | 12 |
Collected over Adverse event data were collected from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 38 months post-dose.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DS-8201a | 0/51 (0%) | 9/51 (17.6%) | 51/51 (100%) |
| Event | DS-8201a |
|---|---|
| NauseaGastrointestinal disorders | 2/51 |
| Femur fractureInjury, poisoning and procedural complications | 1/51 |
| CellulitisInfections and infestations | 1/51 |
| Lung infectionInfections and infestations | 1/51 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 1/51 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/51 |
| Post procedural complicationInjury, poisoning and procedural complications | 1/51 |
| FractureInjury, poisoning and procedural complications | 1/51 |
| Event | DS-8201a |
|---|---|
| NauseaGastrointestinal disorders | 42/51 |
| Neutrophil count decreasedInvestigations | 36/51 |
| White blood cell count decreasedInvestigations | 34/51 |
| AnaemiaBlood and lymphatic system disorders | 32/51 |
| AlopeciaSkin and subcutaneous tissue disorders | 21/51 |
| VomitingGastrointestinal disorders | 21/51 |
| StomatitisGastrointestinal disorders | 21/51 |
| Platelet count decreasedInvestigations | 20/51 |
| ConstipationGastrointestinal disorders | 17/51 |
| DiarrhoeaGastrointestinal disorders | 17/51 |
| Age, Continuous(years) | DS-8201a |
|---|---|
| Mean | 55.9 ± 10.48 |
| Age, Customized(Participants) | DS-8201a |
|---|---|
| <65 | 38 |
| ≥65 | 13 |
| >75 | 1 |
| Sex: Female, Male(Participants) | DS-8201a |
|---|---|
| Female | 51 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | DS-8201a |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 51 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | DS-8201a |
|---|---|
| Japan | 51 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Data sharing details ↗ · vivli.org
Ran from Dec 2017 to primary completion in Dec 2018, 11 months.
Results were first posted in Jun 2021, 2 years 6 months after primary completion.
Of 388 industry-sponsored phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's 11 months is below that.
Counting every sponsor, half of 759 studies reached it within 44 months; a quarter within 25 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trastuzumab deruxtecan