Breast NeoplasmsPhase 1NCT03153163
Study of the Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Participants With Locally Advanced Inoperable or Metastatic HER2+ Breast Cancer
A Phase 1 study testing Trastuzumab Emtansine in people with Breast Neoplasms, run by Hoffmann-La Roche at 1 site in China.
Trial summary
This is an open-label Phase I study of single-agent trastuzumab emtansine administered by intravenous (IV) infusion. The study will characterize the pharmacokinetics of trastuzumab emtansine and its relevant analytes and the safety of trastuzumab emtansine in Chinese participants with human epidermal growth factor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Trastuzumab Emtansine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2017to 27 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prospective centrally-assessed HER2-positive disease (i.e., immunohistochemistry [IHC] 3 + and/or gene amplified [HER2 to CEP 17 ratio ≥ 2] by in situ hybridization [ISH]) through use of archival paraffin-embedded tumor tissue. Both IHC and ISH assays will be performed; however, only one positive result from either method is required for eligibility
- Tumor tissue block or eight unstained freshly cut slides must be available for central laboratory HER2 testing. Archival tumor samples obtained from primary and/or metastatic sites are acceptable
- For participants with bilateral BC, HER2-positive status must be demonstrated in both locations or in a metastatic site
- Histologically or cytologically confirmed invasive breast cancer (BC): incurable, unresectable, LABC previously treated with multimodality therapy or metastatic breast cancer (MBC)
- Prior treatment for BC in the adjuvant, unresectable, locally advanced, or metastatic setting must include taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced, or metastatic setting
- Documented progression of incurable, unresectable LABC or MBC: Progression must occur during or after most recent treatment for LABC or MBC or within 6 months after completing adjuvant therapy
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- Baseline disease that must be evaluable per Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1). Participants with CNS-only disease are excluded
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
- Left ventricular ejection fraction (LVEF) ≥50% by either echocardiogram (ECHO) or multiple-gated acquisition (MUGA)
Who cannot join
- Prior treatment with trastuzumab emtansine, lapatinib, or capecitabine
- Last dose of prior chemotherapy or trastuzumab within 21 days before the first dose of study treatment
- Hormonal therapy within 7 days before the first dose of study treatment
- Treatment with any other anti-cancer therapy/investigational drug (not defined above) within 21 days prior to randomization, except hormone therapy, which can be given up to 7 days prior to randomization; recovery of treatment-related toxicity consistent with other eligibility criteria before the first dose of treatment
- Radiation therapy within 2 weeks before the first dose of study treatment, and with any related acute toxicity (Grade ≥1)
- Brain metastases that are untreated, symptomatic, progressive, or require therapy, such as radiation or surgery, within 28 days before the first dose of study treatment
Show all 20Show fewer
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, synchronous or previously diagnosed HER2-positive BC, or cancers with a similar curative outcome as those mentioned above
- Peripheral neuropathy Grade ≥3 per National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.03
- History of exposure to the following cumulative doses of anthracyclines as specified below:
- Doxorubicin > 500 mg/m^2
- Epirubucin > 720 mg/m^2
- Mitoxantrone > 120 mg/m^2 If another anthracycline or more than one anthracycline has been used, then the cumulative dose must not exceed the equivalent of 500 mg/m^2 doxorubicin.
- Cardiopulmonary dysfunction as defined by:
- Uncontrolled hypertension (persistent systolic blood pressure >150 millimeter of mercury (mmHg) and/or diastolic blood pressure >100 mmHg despite anti-hypertensive therapy)
- Unstable angina or serious cardiac arrhythmia not controlled by medication
- Baseline LVEF <50% by either ECHO or MUGA scan
- History of symptomatic congestive heart failure (Grade ≥3 per NCI CTCAE v4.03 or Class ≥II per New York Heart Association criteria)
- History of LVEF <40% or symptomatic CHF during prior trastuzumab treatment
- Myocardial infarction within 6 months before the first dose of study treatment
- Current dyspnea at rest because of complications of advanced malignancy or any medical need for continuous oxygen therapy
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center; Medical Oncology
Shanghai, 200032
About this study
Official title: A Phase I Study of Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Patients With Logically Advanced Inoperable or Metastatic HER2-Positive Breast Cancer Who Have Received Prior Trastuzumab Based Therapy
This is an open-label Phase I study of single-agent trastuzumab emtansine administered by intravenous (IV) infusion. The study will characterize the pharmacokinetics of trastuzumab emtansine and its relevant analytes and the safety of trastuzumab emtansine in Chinese participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced/metastatic breast cancer (LA/MBC).
- Conditions
- Breast Neoplasms
- Being tested
- Trastuzumab Emtansine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab EmtansineDrug
Also called RO5304020
Trastuzumab emtansine will be administered by IV infusion at a dose of 3.6 milligrams per kilogram (mg/kg) of body weight, every three weeks (Q3W) until death, disease progression or unmanageable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab Emtansine | Experimental | Participants with HER2-positive LA/MBC who received prior trastuzumab and taxane therapy will receive trastuzumab emtansine. Receives: Drug: Trastuzumab Emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve [AUC] of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
AUC will be evaluated and reported for trastuzumab emtansine and its metabolites.
Measured: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
Maximum Serum Concentration (Cmax) Immediately After Dosing of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
Maximum serum concentration (Cmax) immediately after dosing will be evaluated and reported for trastuzumab emtansine and its metabolites.
Measured: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
Minimum (Trough) Concentration (Cmin) of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
Minimum (Trough) Concentration (Cmin) will be evaluated and reported for trastuzumab emtansine and its metabolites.
Measured: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
Clearance (CL) of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
Clearance (CL) will be evaluated and reported for trastuzumab emtansine and its metabolites.
Measured: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
Volume of Distribution at Steady-State (Vss) of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
Volume of distribution at steady-state (Vss) will be evaluated and reported.
Measured: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
Half-Life (t1/2) of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
Half-life (t1/2) will be evaluated and reported.
Measured: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
Secondary outcomes (1)
Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for AEs, Version 4.03 (NCI CTCAE V4.03)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Measured: Up to (28-42 days) after the last dose of study drug (57 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start20 Jun 2017
- Primary completion27 Sep 2018
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153163
- Sponsor's protocol ID
- BP29920
- Status last verified
- Nov 2018
- First submitted
- 12 May 2017
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Patients With Logically Advanced Inoperable or Metastatic HER2-Positive Breast Cancer Who Have Received Prior Trastuzumab Based Therapy
- ClinicalTrials.gov ID
- NCT03153163
- Acronym / sponsor ID
- BP29920
- Conditions
- Breast Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label Phase I study of single-agent trastuzumab emtansine administered by intravenous (IV) infusion. The study will characterize the pharmacokinetics of trastuzumab emtansine and its relevant analytes and the safety of trastuzumab emtansine in Chinese participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced/metastatic breast cancer (LA/MBC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab Emtansine | Experimental | Drug: Trastuzumab EmtansineParticipants with HER2-positive LA/MBC who received prior trastuzumab and taxane therapy will receive trastuzumab emtansine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Prospective centrally-assessed HER2-positive disease (i.e., immunohistochemistry [IHC] 3 + and/or gene amplified [HER2 to CEP 17 ratio ≥ 2] by in situ hybridization [ISH]) through use of archival paraffin-embedded tumor tissue. Both IHC and ISH assays will be performed; however, only one positive result from either method is required for eligibility
- Tumor tissue block or eight unstained freshly cut slides must be available for central laboratory HER2 testing. Archival tumor samples obtained from primary and/or metastatic sites are acceptable
- For participants with bilateral BC, HER2-positive status must be demonstrated in both locations or in a metastatic site
- Histologically or cytologically confirmed invasive breast cancer (BC): incurable, unresectable, LABC previously treated with multimodality therapy or metastatic breast cancer (MBC)
- Prior treatment for BC in the adjuvant, unresectable, locally advanced, or metastatic setting must include taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced, or metastatic setting
Key exclusion criteria (20 listed)
- Prior treatment with trastuzumab emtansine, lapatinib, or capecitabine
- Last dose of prior chemotherapy or trastuzumab within 21 days before the first dose of study treatment
- Hormonal therapy within 7 days before the first dose of study treatment
- Treatment with any other anti-cancer therapy/investigational drug (not defined above) within 21 days prior to randomization, except hormone therapy, which can be given up to 7 days prior to randomization; recovery of treatment-related toxicity consistent with other eligibility criteria before the first dose of treatment
- Radiation therapy within 2 weeks before the first dose of study treatment, and with any related acute toxicity (Grade ≥1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab EmtansineAlso: RO5304020Trastuzumab emtansine will be administered by IV infusion at a dose of 3.6 milligrams per kilogram (mg/kg) of body weight, every three weeks (Q3W) until death, disease progression or unmanageable toxicity. | Drug | Trastuzumab Emtansine |
Primary outcome
Area Under the Concentration-Time Curve [AUC] of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
Time frame: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
AUC will be evaluated and reported for trastuzumab emtansine and its metabolites.
Maximum Serum Concentration (Cmax) Immediately After Dosing of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
Time frame: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
Maximum serum concentration (Cmax) immediately after dosing will be evaluated and reported for trastuzumab emtansine and its metabolites.
Minimum (Trough) Concentration (Cmin) of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
Time frame: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
Minimum (Trough) Concentration (Cmin) will be evaluated and reported for trastuzumab emtansine and its metabolites.
Clearance (CL) of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
Time frame: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
Clearance (CL) will be evaluated and reported for trastuzumab emtansine and its metabolites.
Volume of Distribution at Steady-State (Vss) of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
Time frame: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
Volume of distribution at steady-state (Vss) will be evaluated and reported.
Half-Life (t1/2) of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1
Time frame: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1
Half-life (t1/2) will be evaluated and reported.
1 secondary outcome
Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for AEs, Version 4.03 (NCI CTCAE V4.03)
Time frame: Up to (28-42 days) after the last dose of study drug (57 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trastuzumab Emtansine in people with Breast Neoplasms, run by Hoffmann-La Roche at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-Time Curve [AUC] of Trastuzumab Emtansine, Total Trastuzumab, N2'-Deacetyl-N2'-(3-Mercapto-1-Oxopropyl)-Maytansine (DM1), Non-reducible Thioether Linkage (MCC)-DM1 and Lys-MCC-DM1 (time frame: Pre-dose, 30 minutes (min), 24, 48, 72/96 hours (hr) post-dose, Day 8, 11, 15, 18 post-dose; Pre-dose, 30 min post-dose Cycle 2 Day 1, Cycle 3 Day 1; Pre-dose Cycle 4 Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.