A Phase 2 interventional study of Neratinib and Trastuzumab in Breast Cancer, sponsored by Puma Biotechnology, Inc.. Completed at 195 sites in 35 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by Puma Biotechnology, Inc. · Phase 2, Interventional, and Treatment
This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 479 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Neratinib · Drug: Paclitaxel
Drug: Trastuzumab · Drug: Paclitaxel
Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Also known as: Herceptin, Herclon
Paclitaxel - 80 mg/m² IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Also known as: Taxol, Abraxane, Onxol, Nov-onxol
Progression-Free Survival
Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.
Time frame: From randomization to disease progression or death, assessed up to 5.3 years
Objective Response Rate
Defined as the percentage of subjects who achieved confirmed tumor response (complete or partial response) 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; and Non-Progressive Disease for non-target lesions, and no new lesions.
Time frame: From randomization to disease progression or last tumor assessment, assessed up to 5.3 years
Duration of Response
Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, disease progression (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, 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; and Non-PD for non-target lesions, and no new lesions.
Time frame: From first response to first PD or death, assessed up to 5.3 years after first subject randomized
Clinical Benefit Rate
Defined as the proportion of patients who achieved overall tumor response (CR or PR) or SD for 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; and Non-PD for non-target lesions, and no new 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 randomization to disease progression or death, assessed up to 5.3 years
Symptomatic or Progressive Central Nervous System (CNS) Lesions
Defined as the time interval from the date of randomization until the first date of CNS symptoms, the imaging examination shows CNS progression or is censored at the last assessable evaluation on study or prior to new anti-cancer therapy, if applicable. If median time to Symptomatic or Progressive CNS Lesions is not estimable, cumulative incidence will be reported instead.
Time frame: From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years
| Milestone | Neratinib + Paclitaxel | Trastuzumab + Paclitaxel |
|---|---|---|
| Started | 242 | 237 |
| Received treatment | 240 | 234 |
| Completed | 27 | 30 |
| Not completed | 215 | 207 |
| Withdrew: Death | 75 | 70 |
| Withdrew: Lost to follow-up | 10 | 5 |
| Withdrew: Withdrawal by subject | 38 | 27 |
| Withdrew: By sponsor due to protocol amendment | 92 | 105 |
Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.
| months | Neratinib + Paclitaxel | Trastuzumab + Paclitaxel |
|---|---|---|
| Progression-Free Survival | 12.9 (11.1 to 14.9) | 12.9 (11.1 to 14.8) |
Defined as the percentage of subjects who achieved confirmed tumor response (complete or partial response) 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; and Non-Progressive Disease for non-target lesions, and no new lesions.
| percentage of participants | Neratinib + Paclitaxel | Trastuzumab + Paclitaxel |
|---|---|---|
| Objective Response Rate | 74.8 (68.8 to 80.1) | 77.6 (71.8 to 82.8) |
Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, disease progression (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, 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; and Non-PD for non-target lesions, and no new lesions.
| months | Neratinib + Paclitaxel | Trastuzumab + Paclitaxel |
|---|---|---|
| Duration of Response | 13.1 (11.1 to 15.4) | 12.9 (11.0 to 15.1) |
Defined as the proportion of patients who achieved overall tumor response (CR or PR) or SD for 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; and Non-PD for non-target lesions, and no new 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.
| percentage of participants | Neratinib + Paclitaxel | Trastuzumab + Paclitaxel |
|---|---|---|
| Clinical Benefit Rate | 88.4 (83.7 to 92.2) | 85.2 (80.1 to 89.5) |
Defined as the time interval from the date of randomization until the first date of CNS symptoms, the imaging examination shows CNS progression or is censored at the last assessable evaluation on study or prior to new anti-cancer therapy, if applicable. If median time to Symptomatic or Progressive CNS Lesions is not estimable, cumulative incidence will be reported instead.
| Participants | Neratinib + Paclitaxel | Trastuzumab + Paclitaxel |
|---|---|---|
| Symptomatic or Progressive Central Nervous System (CNS) Lesions | 20 | 41 |
Collected over From First Dose through 28 days after last dose, assessed up to 5.3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neratinib+Paclitaxel | — | 67/240 (27.9%) | 239/240 (99.6%) |
| Trastuzumab+Paclitaxel | — | 56/234 (23.9%) | 230/234 (98.3%) |
| Event | Neratinib+Paclitaxel | Trastuzumab+Paclitaxel |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 12/240 | 3/234 |
| VomitingGastrointestinal disorders | 7/240 | 1/234 |
| DehydrationMetabolism and nutrition disorders | 7/240 | 1/234 |
| CellulitisInfections and infestations | 0/240 | 6/234 |
| PyrexiaGeneral disorders | 3/240 | 5/234 |
| Metastases to central nervous systemNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/240 | 5/234 |
| Confusional statePsychiatric disorders | 4/240 | 0/234 |
| Accidental overdoseInjury, poisoning and procedural complications | 2/240 | 3/234 |
| Disease progressionGeneral disorders | 3/240 | 0/234 |
| GastroenteritisInfections and infestations | 3/240 | 0/234 |
| Event | Neratinib+Paclitaxel | Trastuzumab+Paclitaxel |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 222/240 | 78/234 |
| AlopeciaSkin and subcutaneous tissue disorders | 126/240 | 133/234 |
| NauseaGastrointestinal disorders | 107/240 | 70/234 |
| VomitingGastrointestinal disorders | 87/240 | 37/234 |
| NeutropeniaBlood and lymphatic system disorders | 77/240 | 79/234 |
| FatigueGeneral disorders | 77/240 | 64/234 |
| Decreased appetiteMetabolism and nutrition disorders | 76/240 | 41/234 |
| LeukopeniaBlood and lymphatic system disorders | 72/240 | 74/234 |
| AnaemiaBlood and lymphatic system disorders | 75/240 | 65/234 |
| RashSkin and subcutaneous tissue disorders | 72/240 | 51/234 |
| Age, Categorical(Participants) | Neratinib + Paclitaxel | Trastuzumab + Paclitaxel | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 199 | 193 | 392 |
| >=65 years | 43 | 44 | 87 |
| Age, Continuous(years) | Neratinib + Paclitaxel | Trastuzumab + Paclitaxel | Total |
|---|---|---|---|
| Mean | 54.0 ± 11.6 | 54.3 ± 11.0 | 54.1 ± 11.3 |
| Sex: Female, Male(Participants) | Neratinib + Paclitaxel | Trastuzumab + Paclitaxel | Total |
|---|---|---|---|
| Female | 242 | 237 | 479 |
| Male | 0 | 0 | 0 |
Showing the first 100 of 195 sites across 35 countries. Choose a country and city above to see the rest.
Ran from Aug 2009 to primary completion in Aug 2013, 48 months.
Results were first posted in Nov 2017, 4 years 3 months after primary completion. A results delay was requested in Nov 2013.
Of 232 industry-sponsored phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 53. This study's 48 months is above that.
Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Neratinib