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Anti-mitotic Agent
Pertuzumab + Trastuzumab + Chemotherapy for Advanced Breast Cancer
Phase 2
Waitlist Available
Led By Joanne Mortimer, MD
Research Sponsored by City of Hope Medical Center
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 up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation to see how well it works in treating HER2-positive stage II-IV breast cancer.
Who is the study for?
This trial is for adults with HER2-positive advanced breast cancer who haven't had chemotherapy or trastuzumab for metastatic disease. They should have adequate blood counts, no serious medical conditions, and not be pregnant. Prior adjuvant therapy is allowed if it was over 12 months ago. Participants must agree to use contraception during the study.
What is being tested?
The trial tests how well a combination of pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation works in treating stage II-IV breast cancer by blocking tumor growth or killing tumor cells.
What are the potential side effects?
Potential side effects include allergic reactions to the drugs, possible damage to heart muscle leading to heart failure (especially since these drugs can affect heart function), nerve damage causing numbness or tingling sensations, and typical chemotherapy-related issues like nausea, fatigue, hair loss, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Five Year Disease-free Survival (LABC Cohort)
Progression Free Survival (MBC Cohort)
Secondary study objectives
Five Year Overall Survival
Overall Response (MBC Cohort)
Side effects data
From 2016 Phase 3 trial • 1095 Patients • NCT0112018452%
Nausea
49%
Diarrhoea
36%
Fatigue
35%
Epistaxis
33%
Headache
32%
Pyrexia
30%
Vomiting
27%
Chills
24%
Rash
23%
Decreased appetite
22%
Cough
19%
Arthralgia
19%
Constipation
19%
Neuropathy peripheral
18%
Nasopharyngitis
18%
Upper respiratory tract infection
17%
Thrombocytopenia
17%
Muscle spasms
17%
Back pain
17%
Myalgia
17%
Asthenia
16%
Anaemia
15%
Pain in extremity
14%
Insomnia
14%
Dyspnoea
14%
Dysgeusia
14%
Pruritus
13%
Abdominal pain upper
13%
Dyspepsia
13%
Peripheral sensory neuropathy
12%
Hypertension
12%
Dry mouth
12%
Paraesthesia
11%
Abdominal pain
11%
Urinary tract infection
11%
Stomatitis
10%
Musculoskeletal pain
10%
Dizziness
10%
Oedema peripheral
10%
Alanine aminotranseferase increased
10%
Neutropenia
10%
Mucosal inflammation
9%
Influenza like illness
9%
Anxiety
9%
Rhinorrhoea
9%
Alopecia
8%
Paronychia
8%
Aspartate aminotransferase increased
8%
Weight decreased
8%
Bone pain
8%
Oropharyngeal pain
8%
Dry skin
8%
Hypokalaemia
7%
Gingival bleeding
7%
Influenza
7%
Dry eye
7%
Dermatitis acneiform
7%
Neck Pain
7%
Non-cardiac chest pain
7%
Rhinitis
6%
Vertigo
6%
Haemorrhoids
5%
Pain
5%
Erythema
5%
Pharyngitis
5%
Nail disorder
5%
Depression
5%
Bronchitis
5%
Onychoclasis
5%
Lacrimation increased
5%
Musculoskeletal chest pain
5%
Conjunctivitis
5%
Gamma- glutamyltranseferase increased
5%
Vision Blurred
4%
Infusion related reaction
4%
Ejection fraction decreased
4%
Breast pain
3%
Hot flush
3%
Palmar-plantar erythrodysaesthesia syndrome
2%
Lymphoedema
1%
Hypersensitivity
1%
Femur fracture
1%
Gastritis
1%
General physical health deterioration
1%
Alanine aminotransferase increased
1%
Oedema
1%
Pleural effusion
1%
Pneumonia
1%
Sepsis
1%
Gastroenteritis
1%
Confusional state
1%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab Emtansine + Pertuzumab
Trastuzumab + Taxane
Trastuzumab Emtansine + Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pertuzumab, trastuzumab, nab-paclitaxel)Experimental Treatment4 Interventions
Patients receive pertuzumab IV over 30-60 minutes on day 1, trastuzumab IV over 30-90 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pertuzumab
2013
Completed Phase 3
~1350
trastuzumab
2002
Completed Phase 3
~1790
paclitaxel albumin-stabilized nanoparticle formulation
2008
Completed Phase 2
~1070
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
599 Previous Clinical Trials
1,923,496 Total Patients Enrolled
42 Trials studying Breast Cancer
4,877 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,986 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,183 Patients Enrolled for Breast Cancer
Joanne Mortimer, MDPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
733 Total Patients Enrolled
2 Trials studying Breast Cancer
621 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not received chemotherapy or trastuzumab for metastatic breast cancer treatment before.If you have metastatic breast cancer, you can participate if you had chemotherapy and trastuzumab more than 12 months ago.Your white blood cell count is at least 3.0 billion cells per liter.You have active hepatitis B or C.You have nerve problems worse than mild.Your heart's pumping ability was less than 50% during previous treatment with trastuzumab.You are able to carry out your normal activities without restrictions or with only a little restriction due to your medical condition.You currently have active HIV.You need to have a certain level of a type of white blood cells called neutrophils in your blood.You don't have any other cancer that is currently growing, except for non-melanoma skin cancer. If you finished treatment for another cancer and have a low chance of it coming back, you can still join the study.You have cancer that has spread to your brain or spinal cord.You have advanced breast cancer that has spread to other parts of your body, or you have a specific type of breast cancer called HER2 over-expression.You have been treated for breast cancer or any other invasive cancer within the last 5 years.Your liver enzymes (AST and ALT) are not more than two times the normal limit.You have not received any treatment for your metastatic breast cancer except for anti-estrogen therapy. If you had chemotherapy for breast cancer in the past, it should have been at least 12 months ago. If you had a different type of cancer more than 5 years ago, you can still participate as long as you have not been treated with nab-paclitaxel before.Your platelet count is at least 100 billion per liter.Your hemoglobin level is at least 9 grams per deciliter.Women who could become pregnant must have a negative pregnancy test.You have received a high dose of doxorubicin or a similar drug as part of previous treatment.You have had a different type of cancer, except for basal cell skin cancer.Your tumor shows specific levels of hormone receptors and HER2 expression, as determined by lab tests.Your total bilirubin level should be no higher than 1.3 mg/dl, which is the normal level in the hospital where the study is taking place.Your kidney function is within the normal range.Your heart is pumping blood normally, as shown by a recent heart test.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pertuzumab, trastuzumab, nab-paclitaxel)
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.
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