RECRUITING

Neratinib in Combination With Ruxolitinib in Patients With mTNBC

Conditions

Metastatic Triple-Negative Breast Carcinoma Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to assess the safety and efficacy of combined ruxolitinib and neratinib in patients with chemotherapy-pretreated metastatic triple negative breast cancer. This trial will evaluate one dosing schedule of neratinib in ruxolitinib in patients with metTNBC with locoregional recurrence.

Official Title

Pilot Clinical Trial Examining the Safety and Efficacy of Neratinib in Combination With Ruxolitinib in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer With Chest Wall Recurrence

Quick Facts

Study Start:2024-09-16

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06008275

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* A patient will be considered for enrollment in this study if all the following criteria are met: 1. Female patients ≥18 years of age 2. Have a diagnosis of metastatic TNBC previously treated with standard anthracycline, cyclophosphamide, and taxane chemotherapy, unless there was a contraindication to doxorubicin, in which case prior treatment with this agent is not required. 3. Have not received more than 4 prior chemotherapy regimens for metastatic disease. Prior platinum and/or taxane therapy in the adjuvant or metastatic setting is permitted. Patients with more than 4 prior regimens may be allowed on study per physician discretion, if ECOG PS is 0-1. 4. Have locoregional (e.g., breast, chest wall, regional lymphatic) or pulmonary or hepatic metastatic disease that is amenable to core needle biopsy. If a research biopsy from a patient's metastatic disease cannot be safely obtained, a skin biopsy is permitted. If a skin biopsy cannot be safely obtained, patients may still be eligible, per physician discretion. 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Have adequate hematologic function, defined by: 1. Absolute neutrophil count (ANC) \>1500/µL 2. Platelet count ≥100,000/ µL 3. Hemoglobin ≥9 g/dL or ≥5.6 mmol/L 7. Have adequate liver function, defined by: 1. AST and ALT ≤2.5 x the upper limit of normal (ULN) or ≤5 x ULN in presence of liver metastases 2. Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels \>1.5 × ULN 8. Have adequate renal function, defined by: 9. Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met: 10. Brain metastases which have been treated 11. Off-treatment with steroids before administration of the first dose of treatment 12. No ongoing requirement for dexamethasone or anti-epileptic drugs 13. No clinical or radiological evidence of progression of brain metastases 14. Patients must be accessible for treatment and follow-up. 15. All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.	* A patient will be ineligible for inclusion in this study any of the following criteria are met: 1. Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study treatment. Administration of killed vaccines is allowed. 2. Has peripheral neuropathy ≥grade 2 3. Has completed previous radiotherapy for metastatic disease \<2 weeks prior to study treatment initiation 4. Has an active infection requiring systemic therapy 5. Has significant cardiovascular disease, such as: 1. History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the last 6 months 2. Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV, or history of CHF NYHA class III or IV. 6. Has a known history of active tuberculosis 7. Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug. 8. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as: 1. severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air 2. liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C). 9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's full participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Treating Physician. 10. Has received prior systemic anti-cancer therapy within 2 weeks prior to study treatment. 11. Has received investigational agents within 4 weeks prior to study treatment. Monoclonal antibody agents should have a 4-week (28 day) washout period. 12. Any other investigational or anti-cancer treatments while participating in this study 13. Any other active malignancy

Inclusion Criteria

Exclusion Criteria

* A patient will be considered for enrollment in this study if all the following criteria are met:
1. Female patients ≥18 years of age
2. Have a diagnosis of metastatic TNBC previously treated with standard anthracycline, cyclophosphamide, and taxane chemotherapy, unless there was a contraindication to doxorubicin, in which case prior treatment with this agent is not required.
3. Have not received more than 4 prior chemotherapy regimens for metastatic disease. Prior platinum and/or taxane therapy in the adjuvant or metastatic setting is permitted. Patients with more than 4 prior regimens may be allowed on study per physician discretion, if ECOG PS is 0-1.
4. Have locoregional (e.g., breast, chest wall, regional lymphatic) or pulmonary or hepatic metastatic disease that is amenable to core needle biopsy. If a research biopsy from a patient's metastatic disease cannot be safely obtained, a skin biopsy is permitted. If a skin biopsy cannot be safely obtained, patients may still be eligible, per physician discretion.
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Have adequate hematologic function, defined by:
1. Absolute neutrophil count (ANC) \>1500/µL
2. Platelet count ≥100,000/ µL
3. Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
7. Have adequate liver function, defined by:
1. AST and ALT ≤2.5 x the upper limit of normal (ULN) or ≤5 x ULN in presence of liver metastases
2. Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels \>1.5 × ULN
8. Have adequate renal function, defined by:
9. Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:
10. Brain metastases which have been treated
11. Off-treatment with steroids before administration of the first dose of treatment
12. No ongoing requirement for dexamethasone or anti-epileptic drugs
13. No clinical or radiological evidence of progression of brain metastases
14. Patients must be accessible for treatment and follow-up.
15. All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.

* A patient will be ineligible for inclusion in this study any of the following criteria are met:
1. Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study treatment. Administration of killed vaccines is allowed.
2. Has peripheral neuropathy ≥grade 2
3. Has completed previous radiotherapy for metastatic disease \<2 weeks prior to study treatment initiation
4. Has an active infection requiring systemic therapy
5. Has significant cardiovascular disease, such as:
1. History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the last 6 months
2. Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV, or history of CHF NYHA class III or IV.
6. Has a known history of active tuberculosis
7. Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.
8. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
1. severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
2. liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's full participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Treating Physician.
10. Has received prior systemic anti-cancer therapy within 2 weeks prior to study treatment.
11. Has received investigational agents within 4 weeks prior to study treatment. Monoclonal antibody agents should have a 4-week (28 day) washout period.
12. Any other investigational or anti-cancer treatments while participating in this study
13. Any other active malignancy

Contacts and Locations

Study Contact

Page E Blas, MA

CONTACT

214-820-5424

page.blas@bswhealth.org

Principal Investigator

Joyce A O'Shaughnessy, MD

PRINCIPAL_INVESTIGATOR

Baylor Scott and White Research Institute

Study Locations (Sites)

Baylor University Medical Center, Baylor Charles A Sammons Cancer Center

Dallas, Texas, 75246

United States

Collaborators and Investigators

Sponsor: Baylor Research Institute

Joyce A O'Shaughnessy, MD, PRINCIPAL_INVESTIGATOR, Baylor Scott and White Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-16

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-09-16

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Triple-Negative Breast Carcinoma
Breast Cancer