Breast CancerPhase 1/2NCT00741260
Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer
A Phase 1/2 study testing Neratinib and Capecitabine in people with Breast Cancer, run by Puma Biotechnology, Inc. at 37 sites in 11 countries.
Trial summary
This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts. In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the combination of neratinib and capecitabine. Each subject will participate in only 1 dose group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neratinib and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 37 sitesin 11 countries
- Study dates
- 9 Dec 2008to Jun 2018
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PART 1:
- confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.
- PART 2:
- confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.
- erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1.
- disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (Prior adjuvant trastuzumab is allowed but not required). A 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.
Show all 10Show fewer
- Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.
- PARTS 1 and 2:
- At least 1 measurable lesion as defined by RECIST criteria.
- LVEF within institutional range of normal as measured by multi-gated acquisition (MUGA) or echocardiogram (ECHO).
Who cannot join
- PART 2:
- prior treatment with capecitabine, lapatinib (20 subjects with prior lapatinib exposure will be enrolled) or any erbB-2 targeted agents except trastuzumab. Treatment with erbB-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.
- prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m², epirubicin dose of greater than 800 mg/m², or the equivalent dose for other anthracyclines.
- PARTS 1 and 2:
- Subjects with bone as the only site of disease.
- Active uncontrolled or symptomatic central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with a history of CNS metastases or cord compression are allowable if they have been considered definitively treated and are off anticonvulsants and steroids for at least 4 weeks before the first dose of test article.
- Any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
Trial locations and contacts
37 sites in 11 countries.
37 sites in 11 countries
United States12 sites
Dayton Clinical Oncology Program
Dayton, Ohio, 45420
The Care Group, LLC. dba Horizon Oncology Center
Lafayette, Indiana, 47905
Arena Oncology Associates, PC
Lake Success, New York, 11042
Pacific Shores Medical Group
Long Beach, California, 90813
University of Southern California
Los Angeles, California, 90033
USA Mitchell Cancer Institute
Mobile, Alabama, 36604
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Kootenai Cancer Center
Post Falls, Idaho, 83854
HOPE Oncology
Richardson, Texas, 75080
Cancer Therapy and Research Center at The UT Health Science Center Institute for Drug Development
San Antonio, Texas, 78229
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110
Berks Hematology Oncology
West Reading, Pennsylvania, 19611
Russia5 sites
Republican Clinical Oncology Dispensary
Kazan', 420029
GUZ Perm Regional Oncology Dispensary
Perm, 614066
Leningrad Regional Oncology Dispensary
Saint Petersburg, 188663
GUZ City Clinical Oncology Dispensary
Saint Petersburg, 197022
Saint-Petersburg State Medical University n.a. acad. I.P. Pavlov, Laboratory of Thoracic Oncology of Pulmonology Research Institute
Saint Petersburg, 197022
China4 sites
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100032
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing, 100071
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Spain4 sites
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Gregorio Maranon
Madrid, 28007
Hospital Clinico San Carlos
Madrid, 28040
Hospital Clínico Universitario de Valencia
Valencia, 46010
South Korea3 sites
Yonsei University Health System-Severance Hospital, Yonsei University College of Medicine
Seoul, 120-752
Department of Hematology/Oncology, Samsung Medical Center
Seoul, 135-710
Asan Medical Center Department of Medicine Division of Oncology
Seoul, 138-736
Australia2 sites
Mater Private Centre for HOCA
South Brisbane, Queensland, 4101
Border Medical Oncology
Wodonga, Victoria, 3690
Brazil2 sites
Associacao Hospital de Caridade Ijui
Ijuí, RS - Brazil, 98700-000
Associacao Hospitalar Moinhos de Vento Instituto de Edicacao e Pesquisa
Porto Alegre, Rio Grande do Sul, 90035-001
Hungary2 sites
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
Budapest, 1122
Josa Andras Oktatokorhaz / Onkoradiologiai Osztaly
Nyíregyháza, 4400
Croatia1 site
University Hospital Center Zagreb Department of Oncology
Zagreb, 10000
Hong Kong1 site
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
Hong Kong
Singapore1 site
Johns Hopkins Singapore International Medical Centre
Singapore, 308433
About this study
Official title: A Phase 1/2, Open-Label Study Of Neratinib (HKI-272) In Combination With Capecitabine In Subjects With Solid Tumors And ErbB-2 Positive Metastatic Or Locally Advanced Breast Cancer
This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts.
In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the combination of neratinib and capecitabine. Each subject will participate in only 1 dose group.
Read more
Additional subjects may be included at any dose level to further assess the safety and tolerability at that dose level.
In Part 2, up to 60 subjects with erbB-2 positive metastatic breast cancer will receive treatment with the combination of neratinib and capecitabine at the maximum tolerated dose level, as determined in Part 1. In addition 20 subjects with prior lapatinib exposure will be enrolled in Part 2.
Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted, if appropriate. In case one test article of the combination is discontinued due to intolerance the other test article can be administered alone.
The primary objectives of Part 1 are to assess the safety and tolerability, and to define the maximum tolerated dose (MTD) of neratinib in combination with capecitabine in subjects with advanced solid tumors.
The primary objective of Part 2 of this study is to confirm the MTD determined in Part 1.
The secondary objective of Part 1 is to collect information on preliminary anti-tumor activity of the combination of neratinib and capecitabine.
Secondary objectives for Part 2 are to collect pharmacokinetic information and to obtain additional efficacy data, such as Objective Response Rate, for subjects with erbB-2 positive breast cancer treated at the MTD of neratinib + capecitabine.
- Conditions
- Breast Cancer
- Being tested
- Neratinib, Capecitabine
- Keywords
- Solid Tumor, erbB2+ Breast Cancer, Prior trastuzumab, Metastatic, Neratinib, HKI-272, Nerlynx, HER2, PB-272
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeratinibDrug
Also called HKI-272
Neratinib orally once daily continually
CapecitabineDrug
Also called Xeloda
Capecitabine orally on days 1-14 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Neratinib and Capecitabine (Dose Level 1) | Experimental | Neratinib 160 mg and Capecitabine 1500 mg/m^2 Receives: Drug: Neratinib; Drug: Capecitabine |
| Neratinib and Capecitabine (Dose Group 2) | Experimental | Neratinib 240 mg and Capecitabine 1500 mg/m^2 Receives: Drug: Neratinib; Drug: Capecitabine |
| Neratinib and Capecitabine (Dose Group 3) | Experimental | Neratinib 240 mg and Capecitabine 2000 mg/m^2 Receives: Drug: Neratinib; Drug: Capecitabine |
| Neratinib and Capecitabine (Dose Group 4) | Experimental | Neratinib 200 mg and Capecitabine 2000 mg/m^2 Receives: Drug: Neratinib; Drug: Capecitabine |
| Neratinib and Capecitabine (Dose Group 5) | Experimental | Neratinib 160 mg and Capecitabine 2000 mg/m^2 Receives: Drug: Neratinib; Drug: Capecitabine |
| Neratinib and Capecitabine MTD (Dose Group 6) | Experimental | Neratinib and Capecitabine Maximum Tolerated Dose without prior lapatinib Receives: Drug: Neratinib; Drug: Capecitabine |
| Neratinib and Capecitabine MTD (Dose Group 7) | Experimental | Neratinib and Capecitabine Maximum Tolerated Dose with prior lapatinib Receives: Drug: Neratinib; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities
Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT).
Measured: From first dose date to day 21
Maximum Tolerated Dose (MTD) of Neratinib
MTD reflects the highest dose of neratinib plus capeciteabine that did not cause a selected Grade 3 toxicity in >= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery [to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks.
Measured: From first dose date to day 21.
Maximum Tolerated Dose (MTD) of Capecitabine
MTD reflects the highest dose of capecitabine in combination with neratinib that did not cause a selected Grade 3 toxicity in >= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery [to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks.
Measured: From first dose date to day 21.
Secondary outcomes (3)
Overall Response Rate
Number of Subjects with Complete or Partial Response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Measured: From first dose date to progression or last tumor assessment, up to three years.
Clinical Benefit Rate
The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From first dose date to progression or last tumor assessment, up to three years.
Duration of Response
Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: 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 three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study start9 Dec 2008
- Primary completionNov 2010
- Study completionJun 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 105 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
- NCT00741260
- Sponsor's protocol ID
- 3144A1-2206 / B1891017
- Status last verified
- Aug 2018
- First submitted
- 22 Aug 2008
- Last updated
- 5 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Saura C, Garcia-Saenz JA, Xu B, Harb W, Moroose R, Pluard T, Cortes J, Kiger C, Germa C, Wang K, Martin M, Baselga J, Kim SB. Safety and efficacy of neratinib in combination with capecitabine in patients with metastatic human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2014 Nov 10;32(32):3626-33. doi: 10.1200/JCO.2014.56.3809. Epub 2014 Oct 6.
PubMed 25287822
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label Study Of Neratinib (HKI-272) In Combination With Capecitabine In Subjects With Solid Tumors And ErbB-2 Positive Metastatic Or Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00741260
- Acronym / sponsor ID
- 3144A1-2206 / B1891017
- Conditions
- Breast Cancer
- Keywords
- Solid Tumor, erbB2+ Breast Cancer, Prior trastuzumab, Metastatic, Neratinib, HKI-272, Nerlynx, HER2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Puma Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2008 (actual)
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Posted 9 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts.
In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the combination of neratinib and capecitabine. Each subject will participate in only 1 dose group.
Additional subjects may be included at any dose level to further assess the safety and tolerability at that dose level.
In Part 2, up to 60 subjects with erbB-2 positive metastatic breast cancer will receive treatment with the combination of neratinib and capecitabine at the maximum tolerated dose level, as determined in Part 1. In addition 20 subjects with prior lapatinib exposure will be enrolled in Part 2.
Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted, if appropriate. In case one test article of the combination is discontinued due to intolerance the other test article can be administered alone.
The primary objectives of Part 1 are to assess the safety and tolerability, and to define the maximum tolerated dose (MTD) of neratinib in combination with capecitabine in subjects with advanced solid tumors.
The primary objective of Part 2 of this study is to confirm the MTD determined in Part 1.
The secondary objective of Part 1 is to collect information on preliminary anti-tumor activity of the combination of neratinib and capecitabine.
Secondary objectives for Part 2 are to collect pharmacokinetic information and to obtain additional efficacy data, such as Objective Response Rate, for subjects with erbB-2 positive breast cancer treated at the MTD of neratinib + capecitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Neratinib and Capecitabine (Dose Level 1) | Experimental | Drug: Neratinib, Drug: CapecitabineNeratinib 160 mg and Capecitabine 1500 mg/m^2 |
| Neratinib and Capecitabine (Dose Group 2) | Experimental | Drug: Neratinib, Drug: CapecitabineNeratinib 240 mg and Capecitabine 1500 mg/m^2 |
| Neratinib and Capecitabine (Dose Group 3) | Experimental | Drug: Neratinib, Drug: CapecitabineNeratinib 240 mg and Capecitabine 2000 mg/m^2 |
| Neratinib and Capecitabine (Dose Group 4) | Experimental | Drug: Neratinib, Drug: CapecitabineNeratinib 200 mg and Capecitabine 2000 mg/m^2 |
| Neratinib and Capecitabine (Dose Group 5) | Experimental | Drug: Neratinib, Drug: CapecitabineNeratinib 160 mg and Capecitabine 2000 mg/m^2 |
| Neratinib and Capecitabine MTD (Dose Group 6) | Experimental | Drug: Neratinib, Drug: CapecitabineNeratinib and Capecitabine Maximum Tolerated Dose without prior lapatinib |
| Neratinib and Capecitabine MTD (Dose Group 7) | Experimental | Drug: Neratinib, Drug: CapecitabineNeratinib and Capecitabine Maximum Tolerated Dose with prior lapatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.
- confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.
- erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1.
- disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (Prior adjuvant trastuzumab is allowed but not required). A 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.
- Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.
Key exclusion criteria (7 listed)
- prior treatment with capecitabine, lapatinib (20 subjects with prior lapatinib exposure will be enrolled) or any erbB-2 targeted agents except trastuzumab. Treatment with erbB-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.
- prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m², epirubicin dose of greater than 800 mg/m², or the equivalent dose for other anthracyclines.
- Subjects with bone as the only site of disease.
- Active uncontrolled or symptomatic central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with a history of CNS metastases or cord compression are allowable if they have been considered definitively treated and are off anticonvulsants and steroids for at least 4 weeks before the first dose of test article.
- Any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
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: HKI-272Neratinib orally once daily continually | Drug | Neratinib and Capecitabine (Dose Group 2), Neratinib and Capecitabine (Dose Group 3), Neratinib and Capecitabine (Dose Group 4), Neratinib and Capecitabine (Dose Group 5), Neratinib and Capecitabine (Dose Level 1), Neratinib and Capecitabine MTD (Dose Group 6), Neratinib and Capecitabine MTD (Dose Group 7) |
| CapecitabineAlso: XelodaCapecitabine orally on days 1-14 of each 21 day cycle | Drug | Neratinib and Capecitabine (Dose Group 2), Neratinib and Capecitabine (Dose Group 3), Neratinib and Capecitabine (Dose Group 4), Neratinib and Capecitabine (Dose Group 5), Neratinib and Capecitabine (Dose Level 1), Neratinib and Capecitabine MTD (Dose Group 6), Neratinib and Capecitabine MTD (Dose Group 7) |
Primary outcome
Number of Participants With Dose Limiting Toxicities
Time frame: From first dose date to day 21
Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT).
Maximum Tolerated Dose (MTD) of Neratinib
Time frame: From first dose date to day 21.
MTD reflects the highest dose of neratinib plus capeciteabine that did not cause a selected Grade 3 toxicity in >= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery [to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks.
Maximum Tolerated Dose (MTD) of Capecitabine
Time frame: From first dose date to day 21.
MTD reflects the highest dose of capecitabine in combination with neratinib that did not cause a selected Grade 3 toxicity in >= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery [to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks.
3 secondary outcomes
Overall Response Rate
Time frame: From first dose date to progression or last tumor assessment, up to three years.
Clinical Benefit Rate
Time frame: From first dose date to progression or last tumor assessment, up to three years.
Duration of Response
Time frame: From start date of response to first PD/death, up to three years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25287822Saura C, Garcia-Saenz JA, Xu B, Harb W, Moroose R, Pluard T, Cortes J, Kiger C, Germa C, Wang K, Martin M, Baselga J, Kim SB. Safety and efficacy of neratinib in combination with capecitabine in patients with metastatic human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2014 Nov 10;32(32):3626-33. doi: 10.1200/JCO.2014.56.3809. Epub 2014 Oct 6.
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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
37 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Neratinib and Capecitabine in people with Breast Cancer, run by Puma Biotechnology, Inc. at 37 sites in 11 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 10 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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Russia, China, Spain, South Korea and 6 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 combined 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.
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 9 Nov 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?
Number of Participants With Dose Limiting Toxicities (time frame: From first dose date to day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00741260, which also lists 1 linked publication.
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 5 Sep 2018.