Triple Negative Breast CancerPhase 2FACT-2NCT03812393

Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast

A Phase 2 study testing Neratinib in people with Triple Negative Breast Cancer and Early-stage Breast Cancer, run by West Cancer Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Neratinib Followed by Weekly Paclitaxel and Carboplatin Plus Neratinib in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Triple Negative Breast Cancer, Early-stage Breast Cancer, HER2-positive Breast Cancer
What is being tested?: Neratinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 21 Jun 2019to 15 Dec 2024
Phase: Phase 2
Are there results?: None posted in the registry

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

The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and i institutional guidelines for the pre-entry research core biopsy for CELx HSF testing and for initiating chemotherapy
Patients must be female.
Patients must be ≥ 18 years old.
Patient must have an ECOG performance status of 0 or 1
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
The primary breast tumor must be palpable and measure ≥ 1.0 cm on physical exam.

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The regional lymph nodes can be cN0 or cN1
The tumor size can be T1c or T2
Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 6 weeks prior to initiating chemotherapy. If suspicious or abnormal, FNA or core biopsy is recommended, also within 6 weeks prior to initiating chemotherapy. Findings of these evaluations will be used to determine the nodal status prior to initiating chemotherapy.
Nodal status - negative
Imaging of the axilla is negative;
Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node(s) on imaging is negative;
Nodal status - positive
FNA or core biopsy of the node(s) is cytologically or histologically suspicious or positive.
Imaging is suspicious or abnormal but FNA or core biopsy was not performed.
Tumor specimen obtained at the time of diagnosis must have estrogen (ER) and progesterone (PR) receptors < 10%.
Tumor specimen obtained at the time of diagnosis must have been determined to be HER2-negative as follows:
Immunohistochemistry (IHC) 0-1+; or
IHC 2+ and ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells; or
ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells.
Blood counts performed within 6 weeks prior to initiating chemotherapy must meet the following criteria:
Absolute neutrophil count (ANC) must be ≥ 1200/mm3;
platelet count must be ≥ 100,000/mm3; and
hemoglobin must be ≥ 10 g/dL.
The following criteria for evidence of adequate hepatic function performed within 6 weeks prior to initiating chemotherapy must be met:
total bilirubin must be ≤ upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
alkaline phosphatase must be ≤ 2.5 x ULN for the lab; and
AST must be ≤ 1.5 x ULN for the lab.
Alkaline phosphatase and AST may not both be > the ULN. For example, if the alkaline phosphatase is > the ULN but ≤ 2.5 x ULN, the AST must be ≤ the ULN. If the AST is > the ULN but ≤ 1.5 x ULN, the alkaline phosphatase must be ≤ ULN. Note: If ALT is performed instead of AST (per institution's standard practice), the ALT value must be ≤ 1.5 x ULN; if both were performed, the AST must be ≤ 1.5 x ULN.
Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT, or PET scan) performed within 6 weeks prior to initiating chemotherapy does not demonstrate metastatic disease and the requirements in criterion 4.2.13 are met.
Patients with alkaline phosphatase that is > ULN but ≤ 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 6 weeks prior to initiating chemotherapy does not demonstrate metastatic disease.
Serum creatinine performed within 6 weeks prior to initiating chemotherapy must be ≤ 1.5 x ULN for the lab.
The left ventricular ejection fraction (LVEF) assessment by echocardiogram or MUGA scan performed within 90 days prior to initiating chemotherapy must be ≥ 50% regardless of the facility's lower limit of normal (LLN).
Patients with reproductive potential must agree to use an effective non-hormonal method of contraception during therapy, and for at least 7 months after the last dose of study therapy.
Patients are candidates for weekly paclitaxel and carboplatin chemotherapy as determined by treating physician.
Patients with multifocal breast cancer are included as long as none of the tumors are HER2 positive by IHC or FISH and targeted lesion meets current inclusion criteria.
Conditions for patient eligibility (Study Enrollment) A patient cannot be considered eligible for this study unless all of the following conditions are met:
The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the FACT-2 study treatment.
Tumor determined to have abnormal HER2-driven signaling activity based on the CELx HSF test.

Who cannot join

T3 or T4 tumors including inflammatory breast cancer.
FNA alone to diagnose the breast cancer.
Excisional biopsy or lumpectomy performed prior to initiating chemotherapy.
Surgical axillary staging procedure prior to initiating chemotherapy. Pre- neoadjuvant therapy sentinel node biopsy is not permitted. (FNA or core biopsy is acceptable.)
Definitive clinical or radiologic evidence of metastatic disease. Required imaging studies must have been performed within 6 weeks prior to initiating chemotherapy.
Synchronous bilateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)

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Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
Previous therapy with anthracycline, taxanes, trastuzumab, or other HER2 targeted therapies for any malignancy.
Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to initiating chemotherapy.)
History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 2 years prior to initiating chemotherapy.
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to:
Active cardiac disease:
angina pectoris that requires the use of anti-anginal medication;
ventricular arrhythmias except for benign premature ventricular contractions;
supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;
conduction abnormality requiring a pacemaker;
valvular disease with documented compromise in cardiac function; and
symptomatic pericarditis.
History of cardiac disease:
myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;
history of documented congestive heart failure (CHF); and
documented cardiomyopathy.
Uncontrolled hypertension defined as sustained systolic BP > 150 mmHg or diastolic BP > 90 mmHg. (Patients with initial BP elevations are eligible prior to initiating chemotherapy if initiation or adjustment of BP medication lowers pressure.)
Active hepatitis B or hepatitis C with abnormal liver function tests.
Intrinsic lung disease resulting in dyspnea.
Poorly controlled diabetes mellitus.
Active infection or chronic infection requiring chronic suppressive antibiotics.
Patients known to be HIV positive.
Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) ≥ grade 2, per the CTCAE v4.0.
Malabsorption syndrome, ulcerative colitis, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function.
Other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or would prevent required follow-up.
Conditions that would prohibit administration of corticosteroids.
Chronic daily treatment with corticosteroids with a dose of ≥ 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).
Known hypersensitivity to any of the study drugs or any of the ingredients or excipients of these drugs (e.g., Cremophor® EL), including sensitivity to benzyl alcohol.
Pregnancy or lactation at the initiation of chemotherapy. (Note: Pregnancy testing must be performed within 2 weeks prior to initiating chemotherapy according to institutional standards for women of childbearing potential).
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Evidence after a clinical examination that the subject's tumor is progressing after treatment with one week of paclitaxel and before a CELx HSF test result is available.
For participation in adherence monitoring: no access to the web via smart phone, tablet or computer

Trial locations and contacts

1 site in 1 country.

United States1 site

West Cancer Center
Germantown, Tennessee, 38139

Other trials in United States

About this study

Official title: Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)

Read the detailed description

This is a prospective, single arm, open label, interventional study designed to evaluate the efficacy of neoadjuvant chemotherapy with a pan-HER inhibitor in patients with ER-/PR-/HER2-(triple-negative) invasive breast cancer who have abnormal HER2-driven signaling activity determined by the Celcuity CELx HER2 signal function (HSF) test. Patients will be required to have a prescreening research core needle biopsy to procure a fresh tumor specimen that will be sent to Celcuity for CELx HSF testing, in order to assess the status of their HER2-driven signaling activity (abnormally or normally active). While waiting for results of the CELx HSF test, patients may receive the first dose of weekly paclitaxel at the investigator's discretion. Patients whose CELx HSF test indicate they have abnormal HER2-driven signaling activity will then receive neratinib as a single agent daily for 21 days and then neratinib plus paclitaxel and carboplatin.

The primary endpoint of the study is to evaluate whether patients with triple-negative breast cancers (estrogen (ER) and progesterone (PR) receptors < 10%; HER2-negative per standard ASCO/CAP testing criteria), but with abnormal HER2-driven signaling pathways determined by the Celcuity CELx HSF assay, and who receive HER2-targeted therapy with neoadjuvant chemotherapy will have a higher rate of pathological complete response (pCR) in the breast and lymph nodes (pCR breast and lymph nodes) than has been found historically in patients with triple-negative breast cancer who have received neoadjuvant chemotherapy. Secondary endpoints include pathologic complete response (breast), clinical complete response (cCR), residual cancer burden (RCB) 0-1 index, and relationship between quantitative CELx score and pCR rate.

It is expected that approximately 135 patients will need to be prescreened in order to enroll 27 patients who have abnormal HER2-driven signaling activity.

Conditions: Triple Negative Breast Cancer, Early-stage Breast Cancer, HER2-positive Breast Cancer
Being tested: Neratinib
Medical subject headings: Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NeratinibDrug
Also called Live Cell HER2 signaling Transduction Analysis (CELx)
For cycle 1 subjects will receive Neratinib 240mg daily for 21 days. For cycle 2-5, subjects will receive carboplatin AUC of 1.5 and Paclitaxel 80mg/m2 on day one in combination with Neratinib 240mg daily for 21 day.

Study groups in NCT03812393
Study group	Role	What they receive
Treatment	Experimental	TNBC patients with HER2 signal positive are treated with neratinib for 3 weeks followed by 12 weeks of neratinib in combination with weekly paclitaxel and carboplatin Receives: Drug: Neratinib

What is being measured

The primary outcome is the main question the study is designed to answer.

The percentage of patients experiencing ≥ 20% response to neratinib only therapy
patient with HER2 positive signal by CELx will be exposed to neratinib to determine response to HER2 therapy
Measured: 4 weeks
rate of pathologic complete response (pCR)
percentage of patients with no tumor in breast at surgery following study treatment
Measured: 15 weeks

Secondary outcomes (5)

Clinical complete response (cCR)
Endpoint Definition: Percentage of patients with clinical complete response rate based on physical examination of the breast and axilla.
Measured: 15 weeks
Residual cancer burden (RCB) 0-1
The measure of the amount of tumor left in breast at surgery following study treatment
Measured: 15 weeks
The PCR rate in patients experiencing greater than or equal to 20% reduction in tumor volume following treatment with neratinib only in cycle 1.
To determine whether a significant decrease in size of tumor can predict whether the rate of complete tumor killing at surgery following study treatment
Measured: 15 weeks
Safety and Toxicity per NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
Measure whether the study treatment is safe and tolerable
Measured: 15 weeks
Increase in the number of patients completing neratinib prescription with the use of web based symptom monitoring
See whether mobile application that connects patient at home to treatment team could increase patients ability to complete drug treatment
Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 201915 Dec 2024

First posted23 Jan 2019
Study start21 Jun 2019
Primary completion15 Dec 2024 (estimated)
Study completion15 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Triple Negative 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: single-arm interventional clinical trial with an early check for futility using a surrogate endpoint
Masking: None (open label)
Enrolment: 27 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03812393
Sponsor's protocol ID: 2018-002
Acronym: FACT-2
Status last verified: Dec 2023
First submitted: 8 Jan 2019
Last updated: 18 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Huang Y, Burns DJ, Rich BE, MacNeil IA, Dandapat A, Soltani SM, Myhre S, Sullivan BF, Furcht LT, Lange CA, Hurvitz SA, Laing LG. A functional signal profiling test for identifying a subset of HER2-negative breast cancers with abnormally amplified HER2 signaling activity. Oncotarget. 2016 Nov 29;7(48):78577-78590. doi: 10.18632/oncotarget.12480.
PubMed 27713176
Huang Y, Burns DJ, Rich BE, MacNeil IA, Dandapat A, Soltani SM, Myhre S, Sullivan BF, Lange CA, Furcht LT, Laing LG. Development of a test that measures real-time HER2 signaling function in live breast cancer cell lines and primary cells. BMC Cancer. 2017 Mar 16;17(1):199. doi: 10.1186/s12885-017-3181-0.
PubMed 28302091

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)
ClinicalTrials.gov ID: NCT03812393
Acronym / sponsor ID: FACT-2 / 2018-002
Conditions: Triple Negative Breast Cancer, Early-stage Breast Cancer, HER2-positive Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 27 participants (estimated)
Lead sponsor: West Cancer CenterUniversity, hospital or other
Collaborators: Celcuity Inc, Puma Biotechnology, Inc.
Study start: 21 Jun 2019 (actual)
Primary completion: 15 Dec 2024 (estimated)
Study completion: 15 Dec 2024 (estimated)
First posted: 23 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

It is expected that approximately 135 patients will need to be prescreened in order to enroll 27 patients who have abnormal HER2-driven signaling activity.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: single-arm interventional clinical trial with an early check for futility using a surrogate endpoint

Arm	Type	Receives
Treatment	Experimental	Drug: NeratinibTNBC patients with HER2 signal positive are treated with neratinib for 3 weeks followed by 12 weeks of neratinib in combination with weekly paclitaxel and carboplatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (39 listed)

The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and i institutional guidelines for the pre-entry research core biopsy for CELx HSF testing and for initiating chemotherapy
Patients must be female.
Patients must be ≥ 18 years old.
Patient must have an ECOG performance status of 0 or 1
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.

Key exclusion criteria (38 listed)

T3 or T4 tumors including inflammatory breast cancer.
FNA alone to diagnose the breast cancer.
Excisional biopsy or lumpectomy performed prior to initiating chemotherapy.
Surgical axillary staging procedure prior to initiating chemotherapy. Pre- neoadjuvant therapy sentinel node biopsy is not permitted. (FNA or core biopsy is acceptable.)
Definitive clinical or radiologic evidence of metastatic disease. Required imaging studies must have been performed within 6 weeks prior to initiating chemotherapy.

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: Live Cell HER2 signaling Transduction Analysis (CELx)For cycle 1 subjects will receive Neratinib 240mg daily for 21 days. For cycle 2-5, subjects will receive carboplatin AUC of 1.5 and Paclitaxel 80mg/m2 on day one in combination with Neratinib 240mg daily for 21 day.	Drug	Treatment

Primary outcome

The percentage of patients experiencing ≥ 20% response to neratinib only therapy
Time frame: 4 weeks
patient with HER2 positive signal by CELx will be exposed to neratinib to determine response to HER2 therapy
rate of pathologic complete response (pCR)
Time frame: 15 weeks
percentage of patients with no tumor in breast at surgery following study treatment

5 secondary outcomes

Clinical complete response (cCR)
Time frame: 15 weeks
Residual cancer burden (RCB) 0-1
Time frame: 15 weeks
The PCR rate in patients experiencing greater than or equal to 20% reduction in tumor volume following treatment with neratinib only in cycle 1.
Time frame: 15 weeks
Safety and Toxicity per NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
Time frame: 15 weeks
Increase in the number of patients completing neratinib prescription with the use of web based symptom monitoring
Time frame: 15 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
Results publication: PubMed 27713176Huang Y, Burns DJ, Rich BE, MacNeil IA, Dandapat A, Soltani SM, Myhre S, Sullivan BF, Furcht LT, Lange CA, Hurvitz SA, Laing LG. A functional signal profiling test for identifying a subset of HER2-negative breast cancers with abnormally amplified HER2 signaling activity. Oncotarget. 2016 Nov 29;7(48):78577-78590. doi: 10.18632/oncotarget.12480.
Results publication: PubMed 28302091Huang Y, Burns DJ, Rich BE, MacNeil IA, Dandapat A, Soltani SM, Myhre S, Sullivan BF, Lange CA, Furcht LT, Laing LG. Development of a test that measures real-time HER2 signaling function in live breast cancer cell lines and primary cells. BMC Cancer. 2017 Mar 16;17(1):199. doi: 10.1186/s12885-017-3181-0.
Individual participant dataSharing planned: No

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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.

Gregory A Vidal, MD.,PhD principal investigator

West Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neratinib in people with Triple Negative Breast Cancer and Early-stage Breast Cancer, run by West Cancer Center at 1 site in United States.

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 39 inclusion and 38 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

The percentage of patients experiencing ≥ 20% response to neratinib only therapy (time frame: 4 weeks). The study lists 2 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 NCT03812393, which also lists 2 linked publications.

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 18 Dec 2023.