Breast NeoplasmsPhase 2NCT00300781
Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
A Phase 2 study testing neratinib in people with Breast Neoplasms and Neoplasms, run by Puma Biotechnology, Inc. at 33 sites in 7 countries.
Trial summary
The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasms
- What is being tested?
- neratinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 33 sitesin 7 countries
- Study dates
- 4 Aug 2006to 30 Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
- Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
- Over-expression of HER2
- Tumor tissue available and adequate for analysis at screening
- At least one measurable lesion
Who cannot join
- Prior treatment with Herceptin (Arm B only)
- More than 4 prior cytotoxic chemotherapy regimens
- Subjects with bone or skin as the only site of measurable disease
- Inadequate cardiac function
- Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
- Active central nervous system metastases
- Pregnant or breastfeeding women
- Inability to swallow the HKI-272 capsules
Trial locations and contacts
33 sites in 7 countries.
33 sites in 7 countries
United States13 sites
University of Colorado Hospital
Aurora, Colorado, 80045
The Cancer Center at GBMC
Baltimore, Maryland, 21204
Oncology Care Associates
Bethesda, Maryland, 20817
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Boston University Medical Center
Boston, Massachusetts, 02118
Faulkner Hospital
Boston, Massachusetts, 02130
The Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Virginia Mason Medical Center
Seattle, Washington, 98101
Louisiana State University
Shreveport, Louisiana, 71103
Midwestern Regional Medical Center
Zion, Illinois, 60099
Russia5 sites
N.N. Blokhin Russian Cancer Research Center of RAMS
Moscow, 115478
Medical Radiological Research Center of RAMS, Department of Radiation and Surgical Methods
Obninsk, 249036
City Oncology Dispensary
Saint Petersburg, 197022
City Hospital N 31 Oncology Haematology Dept. For Adults
Saint Petersburg, 197110
Breast Tumor Department, N.N. Petrov Research Institute of Oncology
Saint Petersburg, 197758
China4 sites
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing, Beijing Municipality, 100071
Cancer Hospital Peking Union Medical College
Beijing, 100021
Chinese People's Liberation Army General Hospital
Beijing, 100853
No. 81 Hospital of Chinese People's Liberation Army
Nanjing, Jiangsu, 210002
India4 sites
Nizam's Institute of Medical Sciences
Hyderabad, Panjagutta, 50082
Tata Memorial Centre
Mumbai, Parel, 400012
Jehangir Clinical Development Centre
Pune, Maharashtra, 411001
Deenanath Mangeshkar Hospital
Pune, Maharashtra, 411004
Belgium3 sites
Institut Jules Bordet Unite du Chimiotherapie
Brussels, 1000
University Hospital Gasthuisberg
Leuven, 3000
St-Augustinus Ziekenhuis Oncology Department
Wilrijk, 2610
Mexico3 sites
Hospital Regional Lic. Adolfo Lopez Mateos Oncología Médica
Mexico City, 01030
Arke Estudios Clínicos S.A. de C.V.
Mexico City, 06700
Hospital de Especialidades MIG
Mexico City, 07300
France1 site
Institut Gustave ROUSSY Service de Pathologie Mammaire
Villejuif, 94805
About this study
Official title: Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer
The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.
Read the detailed description
Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.
- Conditions
- Breast Neoplasms, Neoplasms
- Being tested
- neratinib
- Keywords
- phase 2, HER2+ breast cancer, monotherapy neratinib, HKI-272, Neratinib, Nerlynx, PB-272
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neratinibDrug
Also called Nerlynx, HKI-272
| Study group | Role | What they receive |
|---|---|---|
| Neratinib 240 mg, with prior trastuzumab | Experimental | Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen. Receives: Drug: neratinib |
| Neratinib 240 mg, no prior trastuzumab | Experimental | Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen. Receives: Drug: neratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
16-week Progression Free Survival
16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.
Measured: From first dose to 16 weeks
Secondary outcomes (3)
Objective Response Rate
Percentage of participants with Partial Response (PR) or Complete Response (CR) by independent assessment of tumor per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: From first dose date to progression or last tumor assessment, up to 46 months
Clinical Benefit Rate
Percentage of participants who experienced Complete Response (CR), Partial Response (PR), or Stable Disease (SD) ≥ 24 weeks by independent assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Measured: From first dose date to progression or last tumor assessment, up to 46 months
Duration of Response
Number of weeks between Complete Response (CR) or Partial Response (PR) and the first date of disease progression (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
Measured: From start date of response to first PD/death, up to 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study start4 Aug 2006
- Primary completionApr 2008
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puma Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Puma, Study director, Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300781
- Sponsor's protocol ID
- 3144A1-201 / B1891012
- Status last verified
- Aug 2018
- First submitted
- 7 Mar 2006
- Last updated
- 14 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- 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 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00300781
- Acronym / sponsor ID
- 3144A1-201 / B1891012
- Conditions
- Breast Neoplasms, Neoplasms
- Keywords
- phase 2, HER2+ breast cancer, monotherapy neratinib, HKI-272, Neratinib, Nerlynx, PB-272
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Puma Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2006 (actual)
- Primary completion
- Apr 2008 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 9 Mar 2006 (estimated)
- Results
- Posted 13 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.
Detailed description
Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neratinib 240 mg, with prior trastuzumab | Experimental | Drug: neratinibNeratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen. |
| Neratinib 240 mg, no prior trastuzumab | Experimental | Drug: neratinibNeratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
- Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
- Over-expression of HER2
- Tumor tissue available and adequate for analysis at screening
- At least one measurable lesion
Key exclusion criteria (8 listed)
- Prior treatment with Herceptin (Arm B only)
- More than 4 prior cytotoxic chemotherapy regimens
- Subjects with bone or skin as the only site of measurable disease
- Inadequate cardiac function
- Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 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 |
|---|---|---|
| neratinibAlso: Nerlynx, HKI-272 | Drug | Neratinib 240 mg, no prior trastuzumab, Neratinib 240 mg, with prior trastuzumab |
Primary outcome
16-week Progression Free Survival
Time frame: From first dose to 16 weeks
16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.
3 secondary outcomes
Objective Response Rate
Time frame: From first dose date to progression or last tumor assessment, up to 46 months
Clinical Benefit Rate
Time frame: From first dose date to progression or last tumor assessment, up to 46 months
Duration of Response
Time frame: From start date of response to first PD/death, up to 46 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Puma study director
Biotechnology
33 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neratinib in people with Breast Neoplasms and Neoplasms, run by Puma Biotechnology, Inc. at 33 sites in 7 countries.
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 5 inclusion and 8 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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Russia, China, India, Belgium and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
16-week Progression Free Survival (time frame: From first dose to 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 14 Aug 2018.