CompletedNCT00741260Updated Sep 5, 2018Results posted

Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

A Phase 1/2 interventional study of Neratinib and Capecitabine in Breast Cancer, sponsored by Puma Biotechnology, Inc.. Completed at 37 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Puma Biotechnology, Inc. · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 105
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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.

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 studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,544

Keywords

Solid Tumor
erbB2+ Breast Cancer
Prior trastuzumab
Metastatic
Neratinib
HKI-272
Nerlynx
HER2
PB-272

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 105 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Puma Biotechnology, Inc. is the lead sponsor of 38 studies on the registry; 3 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.
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).

Exclusion criteria

EXCLUSION CRITERIA

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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 105 participants (actual)

Study arms

Experimental
Neratinib and Capecitabine (Dose Level 1)
Neratinib 160 mg and Capecitabine 1500 mg/m\^2
Drug: Neratinib · Drug: Capecitabine
Experimental
Neratinib and Capecitabine (Dose Group 2)
Neratinib 240 mg and Capecitabine 1500 mg/m\^2
Drug: Neratinib · Drug: Capecitabine
Experimental
Neratinib and Capecitabine (Dose Group 3)
Neratinib 240 mg and Capecitabine 2000 mg/m\^2
Drug: Neratinib · Drug: Capecitabine
Experimental
Neratinib and Capecitabine (Dose Group 4)
Neratinib 200 mg and Capecitabine 2000 mg/m\^2
Drug: Neratinib · Drug: Capecitabine
Experimental
Neratinib and Capecitabine (Dose Group 5)
Neratinib 160 mg and Capecitabine 2000 mg/m\^2
Drug: Neratinib · Drug: Capecitabine
Experimental
Neratinib and Capecitabine MTD (Dose Group 6)
Neratinib and Capecitabine Maximum Tolerated Dose without prior lapatinib
Drug: Neratinib · Drug: Capecitabine
Experimental
Neratinib and Capecitabine MTD (Dose Group 7)
Neratinib and Capecitabine Maximum Tolerated Dose with prior lapatinib
Drug: Neratinib · Drug: Capecitabine

Interventions

DrugNeratinib
Neratinib orally once daily continually
Also known as: HKI-272
DrugCapecitabine
Capecitabine orally on days 1-14 of each 21 day cycle
Also known as: Xeloda

What researchers measure

Primary outcomes

Number of Participants With Dose Limiting Toxicities
Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT).
Time frame: 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.
Time frame: 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.
Time frame: From first dose date to day 21.

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: From start date of response to first PD/death, up to three years.

Results

Posted Nov 9, 2017

Participant flow

Participant flow — Overall Study
Milestone	N160 + C1500	N240 + C1500	N240 + C2000	N200 + C2000	N160 + C2000	N + C MTD - No Prior Lap	N + C MTD - Prior Lap
Started	6	8	4	6	9	65	7
Completed	0	0	0	0	0	20	0
Not completed	6	8	4	6	9	45	7
Withdrew: Disease progression	3	5	3	3	5	37	4
Withdrew: Death	0	1	0	1	2	2	1
Withdrew: Withdrawal by subject	0	0	0	0	1	3	1
Withdrew: Physician decision	1	1	0	0	0	0	0
Withdrew: Other	2	1	1	2	1	3	1

Outcome measures

PrimaryNumber of Participants With Dose Limiting Toxicities

Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT).

Time frame:: From first dose date to day 21
Reported as:: Count of participants · Participants

Number of Participants With Dose Limiting Toxicities
Participants	N160 + C1500	N160 + C2000	N200 + C2000	N240 + C1500	N240 + C2000	N + C MTD - No Prior Lap	N + C MTD - Prior Lap
Number of Participants With Dose Limiting Toxicities	0	2	2	0	2	0	0

SecondaryOverall 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.

Time frame:: From first dose date to progression or last tumor assessment, up to three years.
Reported as:: Number · percentage of participants

Overall Response Rate
percentage of participants	Prior Lapatinib Subjects	Lapatinib Naive Subjects P1	Lapatinib Naive Subjects Part 2 + Part 1
Overall Response Rate	57.1 (18.4 to 90.1)	63.9 (50.6 to 75.8)	63.5 (50.4 to 75.3)

SecondaryClinical 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.

Time frame:: From first dose date to progression or last tumor assessment, up to three years.
Reported as:: Number · percentage of participants

Clinical Benefit Rate
percentage of participants	Prior Lapatinib Subjects	Lapatinib Naive Subjects P1	Lapatinib Naive Subjects Part 2 + Part 1
Clinical Benefit Rate	71.4 (29.0 to 96.3)	72.1 (59.2 to 82.9)	73.0 (60.3 to 83.4)

SecondaryDuration 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.

Time frame:: From start date of response to first PD/death, up to three years.
Reported as:: Median · weeks

Duration of Response
weeks	Prior Lapatinib Subjects	Lapatinib Naive Subjects P1	Lapatinib Naive Subjects Part 2 + Part 1
Duration of Response	48.3 (30.0 to 61.0)	46.3 (30.1 to NA)	46.3 (30.1 to NA)

PrimaryMaximum 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.

Time frame:: From first dose date to day 21.
Reported as:: Number · mg

Maximum Tolerated Dose (MTD) of Neratinib
mg	Neratinib in Combination With Capecitabine
Maximum Tolerated Dose (MTD) of Neratinib	240

PrimaryMaximum 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.

Time frame:: From first dose date to day 21.
Reported as:: Number · mg/m^2

Maximum Tolerated Dose (MTD) of Capecitabine
mg/m^2	Capecitabine in Combination With Neratinib
Maximum Tolerated Dose (MTD) of Capecitabine	1500

Adverse events

Collected over From first dose through 28 days after last dose, up to five years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
N160 + C1500	—	5/6 (83.3%)	6/6 (100%)
N240 + C1500	—	4/8 (50%)	8/8 (100%)
N240 + C2000	—	2/4 (50%)	4/4 (100%)
N200 + C2000	—	3/6 (50%)	6/6 (100%)
N160 + C2000	—	3/9 (33.3%)	9/9 (100%)
N + C MTD - No Prior Lap	—	19/65 (29.2%)	62/65 (95.4%)
N + C MTD - Prior Lap	—	2/7 (28.6%)	7/7 (100%)

Most frequent serious events

Showing 10 of 53

Most frequent serious events
Event	N160 + C1500	N240 + C1500	N240 + C2000	N200 + C2000	N160 + C2000	N + C MTD - No Prior Lap	N + C MTD - Prior Lap
PyrexiaGeneral disorders	2/6	0/8	0/4	0/6	1/9	0/65	0/7
DiarrhoeaGastrointestinal disorders	0/6	0/8	1/4	0/6	0/9	1/65	2/7
HypokalaemiaMetabolism and nutrition disorders	0/6	0/8	0/4	0/6	0/9	1/65	2/7
Accidental overdoseInjury, poisoning and procedural complications	0/6	0/8	1/4	0/6	0/9	0/65	0/7
Febrile neutropeniaBlood and lymphatic system disorders	0/6	0/8	0/4	1/6	0/9	0/65	0/7
Pericardial effusionCardiac disorders	1/6	0/8	0/4	0/6	1/9	0/65	0/7
NauseaGastrointestinal disorders	1/6	0/8	0/4	0/6	0/9	1/65	0/7
ChillsGeneral disorders	1/6	0/8	0/4	0/6	0/9	0/65	0/7
Disease progressionGeneral disorders	0/6	1/8	0/4	1/6	0/9	2/65	0/7
PneumoniaInfections and infestations	1/6	0/8	0/4	0/6	0/9	0/65	0/7

Most frequent other events

Showing 10 of 146

Most frequent other events
Event	N160 + C1500	N240 + C1500	N240 + C2000	N200 + C2000	N160 + C2000	N + C MTD - No Prior Lap	N + C MTD - Prior Lap
DiarrhoeaGastrointestinal disorders	5/6	7/8	4/4	6/6	8/9	59/65	7/7
VomitingGastrointestinal disorders	1/6	6/8	2/4	1/6	3/9	21/65	3/7
Decreased appetiteMetabolism and nutrition disorders	0/6	2/8	3/4	4/6	2/9	19/65	2/7
Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders	2/6	2/8	3/4	1/6	4/9	41/65	5/7
NauseaGastrointestinal disorders	2/6	4/8	2/4	3/6	3/9	25/65	4/7
AstheniaGeneral disorders	2/6	4/8	2/4	2/6	5/9	12/65	0/7
InsomniaPsychiatric disorders	0/6	4/8	0/4	0/6	0/9	9/65	0/7
FatigueGeneral disorders	1/6	3/8	1/4	1/6	4/9	15/65	2/7
Mucosal inflammationGeneral disorders	0/6	3/8	1/4	2/6	0/9	9/65	0/7
DehydrationMetabolism and nutrition disorders	0/6	3/8	0/4	0/6	1/9	3/65	0/7

Baseline characteristics

Safety population

Age, Categorical
Age, Categorical(Participants)	N160 + C1500	N240 + C1500	N240 + C2000	N200 + C2000	N160 + C2000	N + C MTD - No Prior Lap	N + C MTD - Prior Lap	Total
<=18 years	0	0	0	0	0	0	0	0
Between 18 and 65 years	5	7	3	3	7	59	7	91
>=65 years	1	1	1	3	2	6	0	14

Age, Continuous
Age, Continuous(years)	N160 + C1500	N240 + C1500	N240 + C2000	N200 + C2000	N160 + C2000	N + C MTD - No Prior Lap	N + C MTD - Prior Lap	Total
Mean	49.7 ± 11.50	53.3 ± 10.42	56.3 ± 17.15	59.0 ± 10.88	55.7 ± 10.64	51.5 ± 10.48	50.9 ± 10.65	52.4 ± 10.77

Sex: Female, Male
Sex: Female, Male(Participants)	N160 + C1500	N240 + C1500	N240 + C2000	N200 + C2000	N160 + C2000	N + C MTD - No Prior Lap	N + C MTD - Prior Lap	Total
Female	4	5	3	3	6	65	7	93
Male	2	3	1	3	3	0	0	12

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	N160 + C1500	N240 + C1500	N240 + C2000	N200 + C2000	N160 + C2000	N + C MTD - No Prior Lap	N + C MTD - Prior Lap	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0
Asian	0	0	0	0	0	25	3	28
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0
Black or African American	1	0	0	0	0	2	0	3
White	5	8	4	6	9	38	4	74
More than one race	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0	0

Study locations

37 sites

USA Mitchell Cancer Institute
Mobile, Alabama 36604, United States
Pacific Shores Medical Group
Long Beach, California 90813, United States
University of Southern California
Los Angeles, California 90033, United States
Florida Hospital Cancer Institute
Orlando, Florida 32804, United States
Kootenai Cancer Center
Post Falls, Idaho 83854, United States
The Care Group, LLC. dba Horizon Oncology Center
Lafayette, Indiana 47905, United States
Washington University School of Medicine Siteman Cancer Center
Saint Louis, Missouri 63110, United States
Arena Oncology Associates, PC
Lake Success, New York 11042, United States
Dayton Clinical Oncology Program
Dayton, Ohio 45420, United States
Berks Hematology Oncology
West Reading, Pennsylvania 19611, United States
HOPE Oncology
Richardson, Texas 75080, United States
Cancer Therapy and Research Center at The UT Health Science Center Institute for Drug Development
San Antonio, Texas 78229, United States
Mater Private Centre for HOCA
South Brisbane, Queensland 4101, Australia
Border Medical Oncology
Wodonga, Victoria 3690, Australia
Associacao Hospital de Caridade Ijui
Ijui, RS - Brazil 98700-000, Brazil
Associacao Hospitalar Moinhos de Vento Instituto de Edicacao e Pesquisa
Porto Alegre, RS 90035-001, Brazil
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing 100021, China
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing 100032, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu 210009, China
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing, 100071, China
University Hospital Center Zagreb Department of Oncology
Zagreb, 10000, Croatia
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
Hong Kong, Hong Kong
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
Budapest, 1122, Hungary
Josa Andras Oktatokorhaz / Onkoradiologiai Osztaly
Nyiregyhaza, 4400, Hungary
Yonsei University Health System-Severance Hospital, Yonsei University College of Medicine
Seoul, 120-752, Korea, Republic of
Department of Hematology/Oncology, Samsung Medical Center
Seoul, 135-710, Korea, Republic of
Asan Medical Center Department of Medicine Division of Oncology
Seoul, 138-736, Korea, Republic of
Republican Clinical Oncology Dispensary
Kazan, 420029, Russian Federation
GUZ Perm Regional Oncology Dispensary
Perm, 614066, Russian Federation
Leningrad Regional Oncology Dispensary
Saint Petersburg, 188663, Russian Federation
GUZ City Clinical Oncology Dispensary
Saint Petersburg, 197022, Russian Federation
Saint-Petersburg State Medical University n.a. acad. I.P. Pavlov, Laboratory of Thoracic Oncology of Pulmonology Research Institute
Saint Petersburg, 197022, Russian Federation
Johns Hopkins Singapore International Medical Centre
Singapore, 308433, Singapore
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Gregorio Maranon
Madrid, 28007, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00741260
Lead sponsor: Puma Biotechnology, Inc.
Responsible party: Sponsor
First posted: Aug 26, 2008
Start date: Dec 9, 2008
Primary completion: Nov 2010
Completion: Jun 2018
Results posted: Nov 9, 2017
Last update: Sep 5, 2018

Study contacts

Puma

study director · Biotechnology

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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