A Phase 2 interventional study of Neratinib and Fulvestrant in Breast Cancer, sponsored by Dana-Farber Cancer Institute. Terminated at 6 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment
Among 39 studies testing neratinib in Breast Neoplasms — 7 open to participants now, 9 under way, 1 of them phase 3. neratinib · Breast Neoplasms.
Among the 39 studies testing neratinib in Breast Neoplasms, this one is the 30th largest by enrollment, is one of 2 that started in 2017, is one of 23 in phase 2, and was the 24th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →7 of the 39 studies testing neratinib in Breast Neoplasms are open now, in 3 countries. Recruiting first, the newest first:
Fudan University · Sites in China
Baylor Research Institute · Sites in United States
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
University Health Network, Toronto · Sites in Canada
Ruth O'Regan · Sites in United States
By country, each count listing its studies:
neratinib: first FDA approval 2017 (NERLYNX), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 31 · Phase 3 3
First in 2003; this study’s year is marked. 2 started in 2017.
This study's enrollment of 21 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 60 across the 39 interventional studies. Of the 26 that completed or were terminated, 21 (81%) have results posted.
This tab as a report to print or save as PDF → With an account.
15 of 39 have an industry lead sponsor. The 10 most frequent:
Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
142 studies in Breast Neoplasms by Dana-Farber Cancer Institute: 15 open now, 43 under way, none of them phase 3. Of 95 finished, 45 (47%) have results posted.
Among the 142 studies in Breast Neoplasms by Dana-Farber Cancer Institute, this one is the 108th largest by enrollment of the 132 interventional ones that give a count, is one of 12 that started in 2017, is one of 56 in phase 2, and was the 81st registered.
Dana-Farber Cancer Institute’s Breast Neoplasms studies by the year they started, since 1998.
3 of the studies testing neratinib in Breast Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04886531Ruth O'ReganTrial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers | 2026-12-22 |
| NCT06008275Baylor Research InstituteNeratinib in Combination With Ruxolitinib in Patients With mTNBC | 2027-06 |
| NCT05388149University Health Network, TorontoKadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease | 2027-07 |
Among the 39 studies testing neratinib in Breast Neoplasms, from their registry updates:
Among Dana-Farber Cancer Institute’s 142 in Breast Neoplasms:
This tab as a report to print or save as PDF → With an account.
This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer .
The interventions involved in this study are:
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has approved Neratinib as a treatment for breast cancer. Fulvestrant has been FDA approved for treatment of metastatic hormone receptor positive breast cancer.
The purpose of this research study is to determine how well neratinib, by itself or together with Fulvestrant, works in treating breast cancer that has spread to other parts of the body. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2).
Neratinib has been used in other research studies and information from those other research studies suggests that neratinib may help to shrink or stabilize HER2-positive breast cancer in this research study.
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.
Participants must have received prior therapy with the following agents in any combination, and in setting (i.e., , adjuvant, metastatic, etc.). These therapies do not need to be the most recent .
Participants must have normal organ and marrow function as described below:
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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 number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Neratinib will be administered orally once daily * Neratinib is dosed at 240mg (six 40mg tablets)
Drug: Neratinib
* Neratinib will be administered orally once daily * Neratinib is dosed at 240mg (six 40mg tablets) * Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle. * Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections).
Drug: Neratinib · Drug: Fulvestrant
Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
Also known as: Nerlynx
Fulvestrant, works in treating breast cancer that has spread to other parts of the body
Also known as: Faslodex
Progression Free Survival
Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease assessment were conducted at baseline and every two cycles after the first cycle.
Time frame: Participants were followed for PFS up to 20.3 months from registration.
Overall Survival
Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. Participants will be evaluated every 6 months for survival until death. Participants removed from protocol therapy for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
Time frame: Participants were followed for up to 38.4 months (3 years and 2 months) from registration to removal from protocol therapy or death.
Overall Response Rate
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; Overall Response Rate(ORR) = (CR + PR)/sample size.
Time frame: 2 years
Duration Of Responses
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).
Time frame: 2 years
| Milestone | Neratinib | Neratinib + Fulvestrant |
|---|---|---|
| Started | 11 | 10 |
| Completed | 10 | 8 |
| Not completed | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Became ineligible prior to treatment start | 0 | 1 |
| Withdrew: Progressed before treatment start | 1 | 0 |
Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease assessment were conducted at baseline and every two cycles after the first cycle.
| months | Neratinib | Neratinib + Fulvestrant |
|---|---|---|
| Less than 4 prior lines of therapy; no prior use of fulvestrant | 19.58 (NA to NA) | 1.74 (NA to NA) |
| More than 3 prior lines of therapy; no prior use of fulvestrant | 1.81 (1.81 to NA) | 3.84 (1.61 to NA) |
| More than 3 prior lines of therapy; prior use of fulvestrant | 6.42 (5.55 to NA) | — |
Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. Participants will be evaluated every 6 months for survival until death. Participants removed from protocol therapy for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
| months | Neratinib | Neratinib + Fulvestrant |
|---|---|---|
| Less than 4 prior lines of therapy; no prior fulvestrant use | NA (NA to NA) | 12.22 (NA to NA) |
| More than 3 prior lines of therapy; no prior fulvestrant use | 20.17 (12.91 to NA) | 19.91 (13.63 to NA) |
| More than 3 prior lines of therapy; prior fulvestrant use | 27.79 (NA to NA) | — |
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; Overall Response Rate(ORR) = (CR + PR)/sample size.
| Participants | Neratinib | Neratinib + Fulvestrant |
|---|---|---|
| Overall Response Rate | 0 | 1 |
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).
| months | Neratinib | Neratinib + Fulvestrant |
|---|---|---|
| Duration Of Responses | NA (NA to NA) | 6.7 (NA to NA) |
Collected over 38.4 months (3 years and 2 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neratinib | 6/10 (60%) | 4/10 (40%) | 10/10 (100%) |
| Neratinib + Fulvestrant | 7/8 (87.5%) | 2/8 (25%) | 8/8 (100%) |
| Event | Neratinib | Neratinib + Fulvestrant |
|---|---|---|
| DehydrationMetabolism and nutrition disorders | 2/10 | 0/8 |
| DiarrheaGastrointestinal disorders | 0/10 | 1/8 |
| Skin infectionInfections and infestations | 0/10 | 1/8 |
| FatigueGeneral disorders | 1/10 | 0/8 |
| MalaiseGeneral disorders | 1/10 | 0/8 |
| SepsisInfections and infestations | 1/10 | 0/8 |
| CPK increasedInvestigations | 1/10 | 0/8 |
| AnorexiaMetabolism and nutrition disorders | 1/10 | 0/8 |
| HyponatremiaMetabolism and nutrition disorders | 1/10 | 0/8 |
| ConfusionPsychiatric disorders | 1/10 | 0/8 |
| Event | Neratinib | Neratinib + Fulvestrant |
|---|---|---|
| DiarrheaGastrointestinal disorders | 8/10 | 5/8 |
| ConstipationGastrointestinal disorders | 7/10 | 5/8 |
| FatigueGeneral disorders | 6/10 | 5/8 |
| NauseaGastrointestinal disorders | 5/10 | 4/8 |
| PainGeneral disorders | 4/10 | 4/8 |
| Aspartate aminotransferase increasedInvestigations | 5/10 | 2/8 |
| AnorexiaMetabolism and nutrition disorders | 1/10 | 4/8 |
| Back painMusculoskeletal and connective tissue disorders | 3/10 | 3/8 |
| Abdominal painGastrointestinal disorders | 2/10 | 2/8 |
| VomitingGastrointestinal disorders | 2/10 | 2/8 |
The analysis population is only including treated patients.
| Age, Continuous(years) | Neratinib | Neratinib + Fulvestrant | Total |
|---|---|---|---|
| Median | 55 (28 to 73) | 55.5 (36 to 66) | 55 (28 to 73) |
| Sex: Female, Male(Participants) | Neratinib | Neratinib + Fulvestrant | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Neratinib | Neratinib + Fulvestrant | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 8 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Neratinib | Neratinib + Fulvestrant | Total |
|---|---|---|---|
| Race — Asian | 0 | 2 | 2 |
| Race — Black or African American | 1 | 0 | 1 |
| Race — Other | 1 | 0 | 1 |
| Race — White | 8 | 6 | 14 |
| Prior use of Fulvestrant(Participants) | Neratinib | Neratinib + Fulvestrant | Total |
|---|---|---|---|
| Yes | 3 | 0 | 3 |
| No | 7 | 8 | 15 |
| Prior lines of therapy(Participants) | Neratinib | Neratinib + Fulvestrant | Total |
|---|---|---|---|
| Less than or equal to 3 lines | 1 | 1 | 2 |
| Greater than 3 lines | 9 | 7 | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Jul 2021, 44 months.
Results were first posted in Mar 2023, 1 year 8 months after primary completion.
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Studies of the drugs tested here: Neratinib · Fulvestrant
Dana-Farber Cancer Institute →