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Chemotherapy
Chemotherapy + HER2-Targeted Therapy With or Without Hormone Therapy for Breast Cancer
Phase 3
Waitlist Available
Led By Mothaffar F Rimawi
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization until death from any cause, assessed up to 8.4 years
Awards & highlights
Pivotal Trial
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is studying a combination of drugs given with or without hormone therapy to see how well they work in treating patients with hormone receptor-positive, HER2-positive breast cancer.
Who is the study for?
This trial is for patients with hormone receptor-positive, HER2-positive breast cancer that's operable or locally advanced. They should have a life expectancy over 10 years (excluding their diagnosis), normal organ function tests, and no history of certain treatments or conditions like previous malignancies within 5 years. Women must agree to non-hormonal contraception during and post-treatment.
What is being tested?
The study compares the effectiveness of chemotherapy drugs (docetaxel, carboplatin) combined with targeted therapy (trastuzumab, pertuzumab) with or without estrogen deprivation using goserelin acetate and aromatase inhibitors in treating this type of breast cancer. It also includes radiation therapy and assesses quality-of-life impacts.
What are the potential side effects?
Potential side effects include reactions to infusion drugs, hormonal changes due to estrogen deprivation therapy, fatigue from chemotherapy and radiation, digestive issues from medications affecting gastrointestinal function, blood disorders such as low platelet counts or anemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from randomization until death from any cause, assessed up to 8.4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization until death from any cause, assessed up to 8.4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent of Patients With Pathological Complete Response (pCR) in the Breast and Post Therapy Lymph Nodes
Secondary study objectives
Change in Endocrine-related Symptoms Using Breast Cancer Prevention Trial (BCPT) Symptom Checklist
Median Percentage of Tumor-infiltrating Lymphocytes (sTILS)
Overall Survival (OS)
+7 moreSide effects data
From 2013 Phase 3 trial • 4312 Patients • NCT0001198695%
Neutropenia
87%
Leukopenia
59%
Anemia
49%
Gastrointestinal
42%
Constitutional
37%
Thrombocytopenia
37%
Pain
24%
Peripheral neurologic
19%
Other Hemotologic
16%
Infection/Fever
14%
Neurologic
14%
Metabolic
12%
Pulmonary
8%
Allergy
8%
2nd Primary
7%
Dermatologic
6%
Musculoskeletal
5%
Cardiovascular
5%
Ocular/Visual
5%
Hepatic
5%
Genitourinary/Renal
4%
Endocrine
3%
Auditory
2%
Hemorrhage
1%
Thrombosis/Embolism
1%
Febrile Neutropenia-Fuo Infect Not Docum
1%
Constipation
1%
Syncope
1%
Vomiting
1%
Abdominal Pain Or Cramping
1%
Infection Documented W Grd 3/4 Neutropn.
1%
Ileus
1%
Coagulation
1%
Allergy-Other
1%
Allergic Reaction/Hypersensitivity
1%
Infection Without Neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carbo/Taxol
Carbo/Taxol/Gemcitabine
Carbo/Taxol/Doxil
Carbo/Topotecan - Carbo/Taxol
Carbo/Gemcitabine - Carbo/Taxol
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (chemo, estrogen deprivation, surgery, radiation)Experimental Treatment11 Interventions
NEOADJUVANT: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I. Premenopausal patients also receive goserelin acetate SC every 28 days until surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Postmenopausal patients receive aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Group II: Arm I (combination chemotherapy, surgery, radiation)Active Control9 Interventions
NEOADJUVANT: Patients receive docetaxel IV over 60 minutes, carboplatin IV over 30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9930
Trastuzumab
FDA approved
Whole Breast Irradiation
2017
N/A
~160
Pertuzumab
FDA approved
Aromatase Inhibition Therapy
2011
Completed Phase 3
~3500
Carboplatin
FDA approved
Docetaxel
FDA approved
Goserelin
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,011,734 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,183 Patients Enrolled for Breast Cancer
NRG OncologyOTHER
237 Previous Clinical Trials
102,459 Total Patients Enrolled
9 Trials studying Breast Cancer
11,639 Patients Enrolled for Breast Cancer
Mothaffar F RimawiPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your AST blood test results must be within a certain range.You are expected to live for at least 10 years, not counting your breast cancer diagnosis.You have already received radiation, chemotherapy, targeted therapy, or hormone therapy for your current breast cancer before joining the study.The patient should have good physical ability, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.You may be included in the study if your alkaline phosphatase is within a specific range or if you do not have unexplained bone pain and recent scans show no signs of cancer spread to the bones.You have a heart condition that makes it unsafe for you to take the drugs used in the treatment.The tumor must have been found to have certain hormone receptors called estrogen receptor (ER) and/or progesterone (PgR) positive.You have a medical condition that prevents you from taking corticosteroids.The tumor must have been confirmed to be HER2-positive.Your bilirubin levels must be within the normal range for the lab.Your high blood pressure is not well controlled.You have a nervous system disorder that is at least moderately severe.You have cancer in both breasts at the same time.You need to have a certain number of infection-fighting white blood cells in your body.You have a condition that affects how your body absorbs nutrients or functions of your stomach or intestines.You have previously been treated with certain types of chemotherapy or targeted therapies for any type of cancer.Your alkaline phosphatase level must be less than or equal to 2.5 times the upper limit of normal on the lab test.Your heart's pumping ability (LVEF) must be at least 50%, no matter what the normal range is at the testing center.Your hemoglobin level must be 10 grams per deciliter or higher.You have previously taken certain medications for cancer treatment.Your recent blood test for creatinine must be within a certain range, or your doctor has to measure your kidney function and it needs to be above a certain level.You have an ongoing infection that needs long-term antibiotics.You can be either before or after menopause when you join the study.You need to have at least 100,000 platelets in a small amount of your blood.There is clear evidence that the cancer has spread to other parts of the body.You have had a previous invasive breast cancer or DCIS on the same side as the current condition.You are not taking any hormonal therapy for your gender.You have HIV and low CD4 count, or you have had certain AIDS-related health issues.The breast cancer diagnosis must have been made using a core needle biopsy.Your doctor must check the lymph nodes in your armpit with imaging within 6 weeks before you can join the study.You have had breast cancer in both breasts at the same time or in the past.You have hepatitis B or hepatitis C with liver function tests showing a problem.The primary tumor can be small or larger, but there should not be any spread to the nearby lymph nodes.Using fine needle aspiration alone to diagnose breast cancer.You have a non-cancerous disease that would make it difficult for you to receive the treatment or follow-up as needed.You have a lung disease that makes it hard to breathe.Your diabetes is not well managed.Your AST or alkaline phosphatase levels are not too high and recent liver imaging shows no sign of cancer spread.You take a high dose of corticosteroid medication every day.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (combination chemotherapy, surgery, radiation)
- Group 2: Arm II (chemo, estrogen deprivation, surgery, radiation)
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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