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Tyrosine Kinase Inhibitor
Combination Chemotherapy for Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Rachel Layman
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological confirmation of breast cancer
Cohort 1: Phase II: patient must have HER2+ (regardless of hormonal receptor status) stage III IBC or Stage IV IBC if the metastatic sites are amenable for local therapy (i.e. radiation and/ or surgery) and will have breast surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing neratinib, pertuzumab, trastuzumab, and paclitaxel as possible treatments for metastatic breast cancer.
Who is the study for?
This trial is for adults with confirmed breast cancer that has spread and who can take oral meds. They must have good heart function, normal blood counts, liver function within certain limits, and agree to use birth control. It's not for those breastfeeding, with a history of certain autoimmune diseases or other recent cancers, uncontrolled high blood pressure, serious infections or hepatitis B/C.Check my eligibility
What is being tested?
The study tests neratinib combined with paclitaxel chemotherapy and possibly pertuzumab and trastuzumab before more chemo. The goal is to find the best dose of neratinib and see how well it works in stopping tumor growth when used with these drugs in metastatic or locally advanced breast cancer.See study design
What are the potential side effects?
Possible side effects include diarrhea from neratinib; allergic reactions, nerve damage from paclitaxel; heart issues from trastuzumab; infusion reactions from pertuzumab; plus typical chemo effects like fatigue, hair loss (from doxorubicin), risk of infection (due to low white cells), bleeding risks (low platelets) from cyclophosphamide.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer diagnosis was confirmed through tissue examination.
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I have HER2+ stage III or IV inflammatory breast cancer and can undergo surgery or radiation.
Select...
My heart's pumping ability is confirmed to be good by a recent test.
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I can carry out all my usual activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of neratinib, pertuzumab, trastuzumab and paclitaxel treatment defined as dose limiting toxicities of grade 3 or higher
Pathologic complete response (pCR) rate determined by pCR in breast and axillary lymph nodes (pCR breast & nodes) in HER2+ and HER2-/hormone receptor (HR)+ inflammatory breast cancer treated with neratinib-based treatment
Secondary outcome measures
Incidence of adverse events of combination therapy
Progression-free survival rate of HER2+, and HER2-/HR+ inflammatory breast cancer subgroups
Side effects data
From 2022 Phase 2 trial • 11 Patients • NCT03094052100%
Diarrhea
100%
Constipation
82%
Nausea
45%
Fatigue
45%
Abdominal distension
36%
Headache
36%
Dizziness
27%
Hot flashes
27%
Pruritus
27%
Dyspnea
27%
Weight loss
27%
Vomiting
27%
Anorexia
18%
Dysgeusia
18%
Alanine aminotransferase increased
18%
Aspartate aminotransferase increased
18%
Fever
18%
Gastrointestinal disorders - Other, specify
18%
Abdominal pain
18%
Bloating
18%
Sinus bradycardia
18%
Skin and subcutaneous tissue disorders - Other, specify
9%
Anxiety
9%
Cholecystitis
9%
Mucositis oral
9%
Paresthesia
9%
Rash maculo-papular
9%
Upper respiratory infection
9%
Fracture
9%
Back pain
9%
Joint range of motion decreased
9%
Vaginal dryness
9%
Lymphedema
9%
Anal hemorrhage
9%
Muscle weakness upper limb
9%
Musculoskeletal and connective tissue disorder - Other, specify
9%
Vaginal hemorrhage
9%
Chills
9%
Vaginal discharge
9%
Gastroesophageal reflux disease
9%
Creatinine increased
9%
Bruising
9%
Vaginal infection
9%
Arthralgia
9%
Pain
9%
Urinary tract pain
9%
Wheezing
9%
Ejection fraction decreased
9%
Peripheral sensory neuropathy
9%
Insomnia
9%
Flatulence
9%
Flu like symptoms
9%
Rash acneiform
9%
Oral dysesthesia
9%
Stomach pain
9%
General disorders and administration site conditions - Other, specify
9%
Infections and infestations - Other, specify
9%
Fall
9%
Neck pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Neratinib)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group C (Cohort 2)Experimental Treatment5 Interventions
Patients receive neratinib PO QD on days 1-21, paclitaxel IV over 1-3 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery/ Patients then receive doxorubicin and cyclophosphamide as in Group B. Patients then undergo standard of care surgery.
Group II: Group B (Cohort 1 Phase II)Experimental Treatment7 Interventions
Patients receive neratinib, paclitaxel, pertuzumab, and trastuzumab as in Group A. Patients then receive doxorubicin IV and cyclophosphamide IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery.
Group III: Group A (Cohort 1 Phase Ib)Experimental Treatment5 Interventions
Patients receive neratinib PO QD on days 1-21, paclitaxel IV over 1-3 hours on days 1, 8, and 15, pertuzumab IV over 1 hour on day 1, and trastuzumab IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression or excessive toxicity with metastatic disease may receive up to 4 additional courses and with locally advanced disease may receive up to 2 additional courses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Neratinib
2014
Completed Phase 2
~1970
Paclitaxel
2011
Completed Phase 4
~5380
Pertuzumab
2014
Completed Phase 3
~7500
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,173 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,446 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Rachel LaymanPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
96 Total Patients Enrolled
1 Trials studying Breast Cancer
56 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had surgery to remove part or all of my breast tumor.I haven't had any cancer except for some skin cancers and treated cervical cancer in the last 5 years.Your platelet count is at least 100,000 per microliter.Your hemoglobin level is at least 9 grams per deciliter.I have not received any cancer treatments for my current diagnosis, except if I'm in phase Ib of cohort 1.I am currently breastfeeding or plan to become pregnant during treatment.I have an autoimmune disease that can cause diarrhea, such as Addison's, celiac, or IBS.I have hepatitis B or C and my liver tests are abnormal.I have a condition that significantly affects my stomach or intestines.I have had ongoing diarrhea of moderate severity.I can take corticosteroids for paclitaxel premedication without any health issues.My blood pressure is not higher than 150/90 mmHg, even with medication.I do not have serious heart problems or a history of such conditions.My breast cancer diagnosis was confirmed through tissue examination.I can take pills by mouth.My total bilirubin levels are within normal range, or I have a condition like Gilbert syndrome with documentation.My liver enzymes are within the acceptable range for the trial.I am using or willing to use effective birth control or abstain from sex during the study and for 4 months after.I have advanced or metastatic HER2 positive breast cancer.I have HER2+ stage III or IV inflammatory breast cancer and can undergo surgery or radiation.I have stage III or IV HER2-/HR+ breast cancer and can undergo surgery or radiation.Your kidneys work well enough to filter out waste products.My heart's pumping ability is confirmed to be good by a recent test.I can carry out all my usual activities without help.You have enough white blood cells called neutrophils.I have moderate to severe numbness, tingling, or muscle weakness.I have an ongoing infection or need long-term antibiotics.
Research Study Groups:
This trial has the following groups:- Group 1: Group C (Cohort 2)
- Group 2: Group A (Cohort 1 Phase Ib)
- Group 3: Group B (Cohort 1 Phase II)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has any other research been conducted on Neratinib?
"Currently, there are 1893 independent investigations into Neratinib with 423 of them in their terminal phase. Most of the trials take place in Seattle, Washington but they span 79307 different sites across the globe."
Answered by AI
To what maladies is Neratinib typically administered?
"Neratinib is often prescribed for the management of cyclophosphamide and can be effective in treating a variety of conditions, including Kaposi's Sarcoma AIDS related, leukemia, and locally advanced non-small cell lung cancer."
Answered by AI
Is the enrollment process for this experiment still open?
"Currently, this study is no longer accepting participants. This investigation was initially posted on January 29th 2018 and had its latest update on July 13th 2022. If you are searching for alternate trials, 4568 studies related to inflammatory breast neoplasms and 1893 clinical investigations concerning Neratinib are currently recruiting patients."
Answered by AI
Is this investigation a pioneering endeavor?
"As of today, there are 1,893 live trials involving Neratinib spanning 86 countries and 3723 cities. The inaugural trial for this drug was sponsored by Alfacell in 1997; it included 300 participants and progressed up to its Phase 3 approval stage. Since then, an additional 3233 studies have been conducted on the medication."
Answered by AI
How many volunteers are taking part in this medical experiment?
"At this time, participants are not being accepted into the clinical trial that was first launched in January of 2018 and last updated on July 13th 2022. If one wishes to explore other medical studies, there are currently 4568 trials actively recruiting patients with inflammatory breast neoplasms and 1893 for Neratinib-related treatments which require enrolment."
Answered by AI
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