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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
Women of childbearing potential and men with partners of childbearing potential must be willing to use contraception
ECOG PS 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights

Study Summary

This trial is studying how well giving two drugs together before surgery works in treating breast 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.Check my eligibility
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.See study design
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 below
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I am willing to use birth control during the trial.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer is Stage II or III and my tumor is at least 1.5 cm big.
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My tumor is HER-2 positive according to tests.
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I can safely receive radiation therapy for my breast cancer.
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All tested areas of my cancer are HER2 positive.
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Both of my breast cancers are HER2 positive, or one is small, ER+ and HER2-.
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I have had DCIS in the same breast before.
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I am 18 years old or older.
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I am a premenopausal woman and have a recent negative pregnancy test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adjuvant chemotherapy Received
Secondary outcome measures
Event-Free Survival (EFS)
One Year of Trastuzumab and Pertuzumab
Overall survival (OS)
+6 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
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

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
~5380
Trastuzumab
2014
Completed Phase 4
~5190
Pertuzumab
2014
Completed Phase 3
~7500

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,306 Total Patients Enrolled
140 Trials studying Breast Cancer
22,471 Patients Enrolled for Breast Cancer
Terri Brodeur Breast Cancer FoundationUNKNOWN
Susan G. Komen Breast Cancer FoundationOTHER
65 Previous Clinical Trials
217,088 Total Patients Enrolled
40 Trials studying Breast Cancer
214,972 Patients Enrolled for Breast Cancer

Media Library

Paclitaxel (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03716180 — Phase 1
Breast Cancer Research Study Groups: Paclitaxel+Trastuzumab+Pertuzumab
Breast Cancer Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT03716180 — Phase 1
Paclitaxel (Microtubule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03716180 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the approximate size of the participant cohort for this clinical trial?

"Unfortunately, recruitment for this medical trial has ceased. It was first posted on November 5th 2018 and received its last update on August 25th 2022. However, 2600 studies that involve breast cancer are currently searching for patients, with 977 of those involving the drug Paclitaxel."

Answered by AI

Could you elucidate the potential hazards of Paclitaxel treatment?

"Paclitaxel's safety and efficacy has only been evaluated in limited clinical settings, so it achieved a score of 1 on our rating system."

Answered by AI

Are there any vacancies currently available for participants in this scientific experiment?

"Contrary to the expectation, clinicaltrials.gov suggests that this particular research initiative is not currently accepting applications. It was first unveiled on November 5th 2018 and was last updated on August 25th 2022; however there are 3577 other experiments actively searching for volunteers right now."

Answered by AI

What therapeutic purposes does Paclitaxel typically address?

"Paclitaxel is most commonly administered to treat metastatic bladder cancer, but can also help individuals afflicted with IBC and AIDS in addition to those suffering from advanced thymoma."

Answered by AI

Has Paclitaxel been previously investigated in the context of other research?

"Currently, 977 Paclitaxel clinical trials are ongoing and 258 of them have reached Phase 3. Seattle, Washington is the most popular setting for these studies with 54383 sites running such investigations."

Answered by AI
~16 spots leftby Mar 2025