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Microtubule Inhibitor
Paclitaxel + Trastuzumab + Pertuzumab for Breast Cancer
Phase 1
Waitlist Available
Led By Adrienne G Waks, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG PS 0 or 1
Patients must have Stage II or III histologically confirmed invasive carcinoma of the breast with a minimum tumor size of 1.5 cm
Must not have
Any prior treatment for the current breast cancer
Significant symptoms (Grade ≥ 2) from peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a combination of three drugs to treat breast cancer. It aims to see if patients' responses can help decide their future treatment. The drugs work by stopping cancer growth and boosting the immune system to fight the cancer.
Who is the study for?
This trial is for adults with Stage II or III HER2-positive invasive breast cancer, who can provide consent and tissue samples. They must have a tumor size of at least 1.5 cm, no serious heart conditions, an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and acceptable blood test results. Pregnant/nursing individuals, those with unresolved infections or significant cardiovascular disease are excluded.
What is being tested?
The DAPHNe study tests if patients/doctors will choose post-surgery treatment based on pre-surgery response to a drug combo: Paclitaxel (Taxol), Trastuzumab (Herceptin), Pertuzumab (Perjeta). It also examines the collected blood/tissue from participants receiving these drugs for treating HER2-positive breast cancer.
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, potential damage to nerves causing numbness/tingling/pain (peripheral neuropathy), lowered white blood cell count increasing infection risk, heart problems due to Herceptin/Pertuzumab affecting cardiac function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My breast cancer is Stage II or III and my tumor is at least 1.5 cm big.
Select...
My tumor is HER-2 positive according to tests.
Select...
I can safely receive radiation therapy for my breast cancer.
Select...
I have had DCIS in the same breast before.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received treatment for my current breast cancer.
Select...
I experience significant discomfort or pain from nerve damage.
Select...
I am currently fighting an infection that hasn't healed.
Select...
I have high blood pressure or heart problems that are not well-managed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adjuvant chemotherapy Received
Secondary study objectives
Event-Free Survival (EFS)
One Year of Trastuzumab and Pertuzumab
Overall survival (OS)
+6 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Headache
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
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: Paclitaxel+Trastuzumab+PertuzumabExperimental Treatment3 Interventions
Paclitaxel is administered intravenously on days 1, 8, and 15 of each 21-day cycle Trastuzumab is administered intravenously on day 1 of each 21-day cycle Pertuzumab is administered intravenously on Day 1 of each 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5810
Trastuzumab
2014
Completed Phase 4
~5190
Pertuzumab
2014
Completed Phase 3
~7500
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The combination of Paclitaxel, Trastuzumab, and Pertuzumab is a common treatment for HER2-positive breast cancer. Paclitaxel, a chemotherapy agent, disrupts cell division, causing cancer cell death.
Trastuzumab and Pertuzumab are monoclonal antibodies that target the HER2 receptor, which is overexpressed in some breast cancers. By blocking HER2 signaling pathways, these drugs inhibit tumor growth and survival.
This targeted approach is crucial for breast cancer patients as it enhances treatment efficacy and can lead to improved clinical outcomes.
Receptor tyrosine kinase inhibitors for the treatment of osteosarcoma and Ewing sarcoma.Compound-therapy based on cancer-immunity cycle: promising prospects for antitumor regimens.Comparative Efficacy and Tolerability of Neoadjuvant Immunotherapy Regimens for Patients with HER2-Positive Breast Cancer: A Network Meta-Analysis.
Receptor tyrosine kinase inhibitors for the treatment of osteosarcoma and Ewing sarcoma.Compound-therapy based on cancer-immunity cycle: promising prospects for antitumor regimens.Comparative Efficacy and Tolerability of Neoadjuvant Immunotherapy Regimens for Patients with HER2-Positive Breast Cancer: A Network Meta-Analysis.
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,103 Previous Clinical Trials
359,275 Total Patients Enrolled
144 Trials studying Breast Cancer
21,719 Patients Enrolled for Breast Cancer
Terri Brodeur Breast Cancer FoundationUNKNOWN
Susan G. Komen Breast Cancer FoundationOTHER
67 Previous Clinical Trials
220,138 Total Patients Enrolled
40 Trials studying Breast Cancer
214,975 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The study requires testing for estrogen receptor (ER) and progesterone receptor (PR) status.I am willing to use birth control during the trial.I have received treatment for my current breast cancer.I am fully active or restricted in physically strenuous activity but can do light work.I experience significant discomfort or pain from nerve damage.My breast cancer is Stage II or III and my tumor is at least 1.5 cm big.My tumor is HER-2 positive according to tests.I do not have any serious diseases that could affect my treatment.Your lab test results need to be within certain limits.I can safely receive radiation therapy for my breast cancer.I am currently fighting an infection that hasn't healed.I have not received IV antibiotics for an infection in the last 7 days.All tested areas of my cancer are HER2 positive.I have high blood pressure or heart problems that are not well-managed.Your breast imaging should include a special ultrasound of the armpit on the same side as the affected breast.Both of my breast cancers are HER2 positive, or one is small, ER+ and HER2-.I have had DCIS in the same breast before.I am 18 years old or older.I am a premenopausal woman and have a recent negative pregnancy test.Your heart's pumping ability is normal, with a left ventricular ejection fraction (LVEF) of 50% or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Paclitaxel+Trastuzumab+Pertuzumab
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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