Metastatic Breast CancerPhase 1STELANCT02073916
T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer
A Phase 1 study testing T-DM1, Lapatinib and Abraxane in people with Metastatic Breast Cancer, run by Jenny C. Chang, MD at 1 site in United States.
Trial summary
This open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- T-DM1, Lapatinib and Abraxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 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
- Documented metastatic Her2 over-expressed breast cancer.
- Age ≥ 18 years Patients must have received at least two prior therapies for their malignant disease.
- Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
- Adequate organ function (cardiac ejection fraction of ≥ 45%),
- CBC not less than .75 of institutional lower limit.
- Patients must have adequate liver function: AST and ALT < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis Bilirubin < 1.5 mg/dL
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- Patients must have adequate renal function: creatinine <1.5 mg/dL is recommended; however, institutional norms are acceptable.
- Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential
- Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed). Contraception method must be used during treatment and for three months after completing treatment Signed informed consent form (ICF)
Who cannot join
- Any medical or psychiatric condition that would prevent informed consent or limit survival to less than 4 weeks.
- Absolute QT interval of >460 msec in the presence of potassium >4.0mEq/L and Magnesium >1.8mg/dl.
- Patient with HIV and post- transplant associated lymphoproliferative disorders.
- Patient with concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of Trastuzumab Emtansine, Lapatinib or Abraxane.
- Pregnant or lactating women.
- Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial
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- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, lapatinib, abraxane, or their components.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
- Subjects with ulcerative colitis are also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib Trial of Trastuzumab Emtansine In Combination With Lapatinib Plus Abraxane In Metastatic Her 2 Neu Over-Expressed Breast Cancer Patients
This open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer.
Read the detailed description
This open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer. Patients will receive Abraxane on Day 1 of each 1-week cycle and T-DM1 on Day 1 of each 3-week cycle. Patients with take Lapatinib orally daily. Patients will receive the study treatment for 12 weeks.
- Conditions
- Metastatic Breast Cancer
- Being tested
- T-DM1, Lapatinib, Abraxane
- Keywords
- Breast Cancer, HER2 positive Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-DM1Drug
Also called Trastuzumab Emtansine, TE, Kadcyla
antibody-drug conjugate of trastuzumab and emtansine
LapatinibDrug
Also called Tykerb
Dual tyrosine kinase inhibitor (HER2 and EGFR)
AbraxaneDrug
Also called nab-paclitaxel
albumin-bound paclitaxel. Chemotherapy - microtubule inhibitor
| Study group | Role | What they receive |
|---|---|---|
| T-DM1 + Lapatinib + Abraxane | Experimental | T-DM1 with Laptinib followed by Abraxane Receives: Drug: T-DM1; Drug: Lapatinib; Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerable Dose
Maximum tolerated dose (MTD) of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer.
Measured: approximately 16 weeks
Secondary outcomes (4)
Dose Limiting Toxicities
Describe the dose-limiting toxicity (DLT) associated with Trastuzumab Emtansine in combination with Lapatinib plus Abraxane as assessed by CTCAE v4.0.
Measured: From date of randomization through study follow up (approximately 16 weeks)
Measure toxicities associated with treatment combination
Describe and measure other toxicities associated with Trastuzumab Emtansine in combination with Lapatinib plus Abraxane as assessed by CTCAE v4.0.
Measured: From date of randomization through study follow up (approximately 16 weeks)
Anti-tumor activity through imaging
Document anti-tumor activity of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer as assessed by RECIST 1:1 criteria
Measured: approximately 16 weeks from randomization
Plasma pharmacokinetics and pharmacodynamic effect of treatment combination
Determine the plasma pharmacokinetics of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane.
Measured: Day 1 and 1,2,4,and 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jenny C. Chang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Responsible party
- Sponsor-investigator, Jenny C. Chang, MD, The Methodist Hospital Research Institute
- Investigators
- Jenny C Chang, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073916
- Sponsor's protocol ID
- Pro00009544
- Other IDs
- 0813-0139
- Acronym
- STELA
- Status last verified
- Apr 2019
- First submitted
- 18 Feb 2014
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Trial of Trastuzumab Emtansine In Combination With Lapatinib Plus Abraxane In Metastatic Her 2 Neu Over-Expressed Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02073916
- Acronym / sponsor ID
- STELA / Pro00009544
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer, HER2 positive Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jenny C. Chang, MDUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 27 Feb 2014 (estimated)
- 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 open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer.
Detailed description
This open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer. Patients will receive Abraxane on Day 1 of each 1-week cycle and T-DM1 on Day 1 of each 3-week cycle. Patients with take Lapatinib orally daily. Patients will receive the study treatment for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T-DM1 + Lapatinib + Abraxane | Experimental | Drug: T-DM1, Drug: Lapatinib, Drug: AbraxaneT-DM1 with Laptinib followed by Abraxane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Documented metastatic Her2 over-expressed breast cancer.
- Age ≥ 18 years Patients must have received at least two prior therapies for their malignant disease.
- Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
- Adequate organ function (cardiac ejection fraction of ≥ 45%),
- CBC not less than .75 of institutional lower limit.
Key exclusion criteria (9 listed)
- Any medical or psychiatric condition that would prevent informed consent or limit survival to less than 4 weeks.
- Absolute QT interval of >460 msec in the presence of potassium >4.0mEq/L and Magnesium >1.8mg/dl.
- Patient with HIV and post- transplant associated lymphoproliferative disorders.
- Patient with concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of Trastuzumab Emtansine, Lapatinib or Abraxane.
- Pregnant or lactating women.
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 |
|---|---|---|
| T-DM1Also: Trastuzumab Emtansine, TE, Kadcylaantibody-drug conjugate of trastuzumab and emtansine | Drug | T-DM1 + Lapatinib + Abraxane |
| LapatinibAlso: TykerbDual tyrosine kinase inhibitor (HER2 and EGFR) | Drug | T-DM1 + Lapatinib + Abraxane |
| AbraxaneAlso: nab-paclitaxelalbumin-bound paclitaxel. Chemotherapy - microtubule inhibitor | Drug | T-DM1 + Lapatinib + Abraxane |
Primary outcome
Maximum Tolerable Dose
Time frame: approximately 16 weeks
Maximum tolerated dose (MTD) of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer.
4 secondary outcomes
Dose Limiting Toxicities
Time frame: From date of randomization through study follow up (approximately 16 weeks)
Measure toxicities associated with treatment combination
Time frame: From date of randomization through study follow up (approximately 16 weeks)
Anti-tumor activity through imaging
Time frame: approximately 16 weeks from randomization
Plasma pharmacokinetics and pharmacodynamic effect of treatment combination
Time frame: Day 1 and 1,2,4,and 24hours
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 16 Apr 2019.
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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.
Jenny C Chang, MD principal investigator
The Methodist Hospital Research Institute
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 T-DM1, Lapatinib and Abraxane in people with Metastatic Breast Cancer, run by Jenny C. Chang, MD at 1 site in United States.
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 9 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 16 Apr 2019. 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 United States. 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?
Maximum Tolerable Dose (time frame: approximately 16 weeks). 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 16 Apr 2019.