Advanced Breast CancerPhase 1NCT01976169
Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1)
A Phase 1 study testing PD-0332991 and T-DM1 in people with Advanced Breast Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Standard of care: Treatment with Trastuzumab Experimental: 21-Day Cycle of Combination therapy with T-DM1 intravenously on Day 1 and oral PD-0332991 on Days 5-18 Study Design and Methodology: This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T-DM1 in patients with recurrent or… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- PD-0332991 and T-DM1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2014to 19 May 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.All subjects must be informed about the study and have signed a current IRB (Institutional Review Board) approved informed consent.
- 2. All subjects must have recurrent or metastatic HER2-positive breast cancer. diagnosed by biopsy.
- 3. All subjects must have previously received trastuzumab or other HER2 targeted therapies.
- 4.Tumor must be HER2-positive and RB-proficient. RB (Retinoblastoma protein)-proficiency is determined by tumor biopsy demonstrating RB normal and p16in4a low by immunohistochemistry. RB proficiency means that there is an intact RB pathway indicative of responsiveness to PD-0332991. RB staining is scored on an absent (no nuclear staining), weak (nuclear staining less than observed in endothelial cells and stromal cells surrounding the tumor), positive (nuclear staining at or above surrounding tissue) (0, 0.5, 1 respectively). P16ink4a is a routine clinical stain that is scored using absent, weak, positive, strong (0,1,2,3 respectively). Tumors will be scored using [p16]/[RB], where a score of less than 3 is required for inclusion. RB loss is expected to occur in less than 15% of cases.
- 5. Subjects must have a performance status of ≤ 2 on the ECOG (Eastern Cooperative Oncology Group)Performance scale.
- 6. Subjects must have bilirubin <1.5 mg/dl, transaminases <2.5x upper limit of normal, albumin >3gm/dl, creatinine <1.3mg/dl, adequate cardiac reserve (EF>50%), ANC (Absolute neutrophil count) >1,000/mcL (microliter), and Platelets >100,000/mcL.
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- 7. Must be willing to be treated at the University of Texas Southwestern Hospital, University of Pennsylvania and affiliated clinics.
- 8. Subjects must be willing to use an approved form of birth control while on this study and for 90 days after completion.
- 9. Age > 18 years. 10. Subject must be able to swallow capsules and have no surgical or anatomic condition that will preclude the subject from swallowing and absorbing oral medications on an ongoing basis.
Who cannot join
- 1. Chemotherapy, radiotherapy or hormonal therapy within 3 weeks ( 6 weeks for nitrosoureas, mitomycin C or bevacizumab), or who have not recovered from the adverse events to < grade 2 due to previous agents administered more than 4 weeks prior to Study Day 1.
- 2. Subjects less than 4 weeks post major surgery. 3. Known active CNS metastases or carcinomatous meningitis. Subjects with CNS (Central Nervous System) metastases including brain metastases who have completed a course of radiotherapy are eligible for the study provided they are clinically stable. However, oral corticosteroids for control of CNS symptoms are not allowed.
- 4. Known documented or suspected hypersensitivity to the components of the study drug(s) or analogs.
- 5. Uncontrolled systemic illness, including but not limited to ongoing or active infection.
- 6. Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months.
- 7. Baseline neuropathy >grade 1. 8. Known positive for human immunodeficiency virus (HIV). Baseline HIV screening is not required.
- 9. Pregnant or breast-feeding subjects. 10. Subjects who are unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1B Study of PD-0332991 in Combination With T-DM1 in the Treatment of Patients With Advanced HER2 (Human Epidermal Growth Factor Receptor 2)-Positive Breast Cancer
Standard of care:
Treatment with Trastuzumab
Read more
Experimental:
21-Day Cycle of Combination therapy with T-DM1 intravenously on Day 1 and oral PD-0332991 on Days 5-18
Study Design and Methodology:
This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior trastuzumab or other HER2-directed therapies.
The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment.
A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle.
Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral)
The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level
Treatment cycles will continue until disease progression or withdrawal from study.
Read the detailed description
This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T--DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior trastuzumab or other HER2-directed therapies. A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts. The 3+3 design entails that if one patient out of the first three patients has a dose-limiting toxicity (DLT), three additional patients will be entered at that dose level. The PD-0332991 dose levels will start at 100 mg po daily; the second cohort will receive 150mg po daily; the third cohort 200mg po daily. Patients receive PD-0332991 on days 5-18 of each 21 day cycle. T-DM1 will be given intravenously at 3.6 mg/kg on day 1 of each 21 day cycle.
Toxicity will be assessed using the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0 grading scale. Dose- limiting toxicity-DLT is defined as any drug-related grade 3 non-hematologic toxicity or grade 4 hematologic toxicity lasting >28 days after the last day of therapy. If two patients experience drug-related DLT, the maximal tolerated dose (MTD) for the combination in HER2-positive breast cancer patients has been exceeded, enrollment to that dose will stop, and the next lower dose will be designated the MTD. An additional 15 patients will be treated at the MTD or the maximal 200mg po daily PD-0332991 dose in combination with T-DM1 to confirm safety. Treatment cycles will continue until disease progression or withdrawal from study.
Study End-points:
- To evaluate and assess Dose Limiting Toxicities (DLT).
- To determine the toxicity profile.
- To determine the clinical response rate.
- To determine the duration of response.
- To evaluate baseline HER2 positivity biomarkers by analyzing pretreatment tumor Ki67, phospho-RB, cleaved caspase 3, phospho-histone H3, cycline E, MCM7, HER2, p27Kip1.
- To evaluate post-treatment Ki67, phospho-RB, cleaved caspase 3, phospho-histone H3, cyclin E, MCM7, HER2, p27Kip1, Rb, p16ink4c, CDK4, CDK6 in order to establish biomarker response to treatment.
- To evaluate pharmacokinetic (PK) parameters for PD-0332991 and T-DM1 including Cmax, AUC, t1/2
- Conditions
- Advanced Breast Cancer
- Being tested
- PD-0332991 and T-DM1
- Keywords
- Breast Cancer, Advanced 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.
PD-0332991 and T-DM1Drug
Also called KADCYLA=T-DM1, Palbociclib=PD-0332991
The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment.
A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle.
Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral)
| Study group | Role | What they receive |
|---|---|---|
| PD-0332991 and T-DM1 | Experimental | The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment.
A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle.
Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral) Receives: Drug: PD-0332991 and T-DM1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle.
Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral)
Measured: 42 days at the end of Cycle 2
Dose Limiting Toxicities (DLT)
The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level
Measured: 42 days at the end of Cycle 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study start24 Jan 2014
- Primary completion19 May 2021
- Study completion19 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Barbara Haley, MD, Principal investigator, Internal Medicine Hematology Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976169
- Sponsor's protocol ID
- STU 042013-042
- Status last verified
- Jan 2022
- First submitted
- 29 Oct 2013
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B Study of PD-0332991 in Combination With T-DM1 in the Treatment of Patients With Advanced HER2 (Human Epidermal Growth Factor Receptor 2)-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01976169
- Acronym / sponsor ID
- STU 042013-042
- Conditions
- Advanced Breast Cancer
- Keywords
- Breast Cancer, Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer, University of Pennsylvania
- Study start
- 24 Jan 2014 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 5 Nov 2013 (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.
Standard of care:
Treatment with Trastuzumab
Experimental:
21-Day Cycle of Combination therapy with T-DM1 intravenously on Day 1 and oral PD-0332991 on Days 5-18
Study Design and Methodology:
This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior trastuzumab or other HER2-directed therapies.
The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment.
A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle.
Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral)
The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level
Treatment cycles will continue until disease progression or withdrawal from study.
Detailed description
This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T--DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior trastuzumab or other HER2-directed therapies. A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts. The 3+3 design entails that if one patient out of the first three patients has a dose-limiting toxicity (DLT), three additional patients will be entered at that dose level. The PD-0332991 dose levels will start at 100 mg po daily; the second cohort will receive 150mg po daily; the third cohort 200mg po daily. Patients receive PD-0332991 on days 5-18 of each 21 day cycle. T-DM1 will be given intravenously at 3.6 mg/kg on day 1 of each 21 day cycle.
Toxicity will be assessed using the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0 grading scale. Dose- limiting toxicity-DLT is defined as any drug-related grade 3 non-hematologic toxicity or grade 4 hematologic toxicity lasting >28 days after the last day of therapy. If two patients experience drug-related DLT, the maximal tolerated dose (MTD) for the combination in HER2-positive breast cancer patients has been exceeded, enrollment to that dose will stop, and the next lower dose will be designated the MTD. An additional 15 patients will be treated at the MTD or the maximal 200mg po daily PD-0332991 dose in combination with T-DM1 to confirm safety. Treatment cycles will continue until disease progression or withdrawal from study.
Study End-points:
- To evaluate and assess Dose Limiting Toxicities (DLT).
- To determine the toxicity profile.
- To determine the clinical response rate.
- To determine the duration of response.
- To evaluate baseline HER2 positivity biomarkers by analyzing pretreatment tumor Ki67, phospho-RB, cleaved caspase 3, phospho-histone H3, cycline E, MCM7, HER2, p27Kip1.
- To evaluate post-treatment Ki67, phospho-RB, cleaved caspase 3, phospho-histone H3, cyclin E, MCM7, HER2, p27Kip1, Rb, p16ink4c, CDK4, CDK6 in order to establish biomarker response to treatment.
- To evaluate pharmacokinetic (PK) parameters for PD-0332991 and T-DM1 including Cmax, AUC, t1/2
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-0332991 and T-DM1 | Experimental | Drug: PD-0332991 and T-DM1The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment. A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle. Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.All subjects must be informed about the study and have signed a current IRB (Institutional Review Board) approved informed consent.
- 2. All subjects must have recurrent or metastatic HER2-positive breast cancer. diagnosed by biopsy.
- 3. All subjects must have previously received trastuzumab or other HER2 targeted therapies.
- 4.Tumor must be HER2-positive and RB-proficient. RB (Retinoblastoma protein)-proficiency is determined by tumor biopsy demonstrating RB normal and p16in4a low by immunohistochemistry. RB proficiency means that there is an intact RB pathway indicative of responsiveness to PD-0332991. RB staining is scored on an absent (no nuclear staining), weak (nuclear staining less than observed in endothelial cells and stromal cells surrounding the tumor), positive (nuclear staining at or above surrounding tissue) (0, 0.5, 1 respectively). P16ink4a is a routine clinical stain that is scored using absent, weak, positive, strong (0,1,2,3 respectively). Tumors will be scored using [p16]/[RB], where a score of less than 3 is required for inclusion. RB loss is expected to occur in less than 15% of cases.
- 5. Subjects must have a performance status of ≤ 2 on the ECOG (Eastern Cooperative Oncology Group)Performance scale.
Key exclusion criteria (7 listed)
- 1. Chemotherapy, radiotherapy or hormonal therapy within 3 weeks ( 6 weeks for nitrosoureas, mitomycin C or bevacizumab), or who have not recovered from the adverse events to < grade 2 due to previous agents administered more than 4 weeks prior to Study Day 1.
- 2. Subjects less than 4 weeks post major surgery. 3. Known active CNS metastases or carcinomatous meningitis. Subjects with CNS (Central Nervous System) metastases including brain metastases who have completed a course of radiotherapy are eligible for the study provided they are clinically stable. However, oral corticosteroids for control of CNS symptoms are not allowed.
- 4. Known documented or suspected hypersensitivity to the components of the study drug(s) or analogs.
- 5. Uncontrolled systemic illness, including but not limited to ongoing or active infection.
- 6. Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months.
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 |
|---|---|---|
| PD-0332991 and T-DM1Also: KADCYLA=T-DM1, Palbociclib=PD-0332991The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment. A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle. Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral) | Drug | PD-0332991 and T-DM1 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 42 days at the end of Cycle 2
A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle. Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral)
Dose Limiting Toxicities (DLT)
Time frame: 42 days at the end of Cycle 2
The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level
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 8 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Barbara Haley, MD principal investigator
Internal Medicine Hematology Oncology
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 PD-0332991 and T-DM1 in people with Advanced Breast Cancer, run by University of Texas Southwestern Medical Center 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 7 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 8 Feb 2022. 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 Tolerated Dose (MTD) (time frame: 42 days at the end of Cycle 2). The study lists 2 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 8 Feb 2022.