DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2030-09-01

Brief Summary

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This research study is studying whether participants and their doctors are willing to determine post-surgery treatment on the basis of response to pre-surgery treatment, and studying blood and tissue collected from participants treated with a combination of drugs as a treatment for breast cancer.

The names study drugs involved in this study are:

* Paclitaxel (also called Taxol)
* Trastuzumab (also called Herceptin)
* Pertuzumab (also called Perjeta)

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Detailed Description

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This research study is a Pilot Study, which means investigators are looking at the feasibility of a new approach for deciding the optimal medical treatment for this type of breast cancer. The FDA (the U.S. Food and Drug Administration) has approved paclitaxel, trastuzumab, and pertuzumab as part of a pre-operative treatment option for this disease.

The purpose of this study is to evaluate whether participants and their doctors are willing to accept a treatment recommendation for post-operative chemotherapy, on the basis of the participant's response to pre-operative treatment with paclitaxel, trastuzumab, and pertuzumab.

In addition, the investigators are evaluating how the body's immune system works with paclitaxel, trastuzumab, and pertuzumab to kill cancer cells. For this reason, the investigators will collect samples of the participant's breast tumor and samples of the participant's blood over time to understand the reaction of the immune system to the participant's tumor.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paclitaxel+Trastuzumab+Pertuzumab

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

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

Paclitaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug

Trastuzumab

Intervention Type DRUG

Trastuzumab works by targeting the HER2/neu receptor on cancer cells

Pertuzumab

Intervention Type DRUG

Pertuzumab is a monoclonal antibody which targets the surface of the cells human epidermal growth factor receptor 2 protein (HER2) on the cancer cell, interfering with HER2 causing cancer cell death

Interventions

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Paclitaxel

Paclitaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug

Intervention Type DRUG

Trastuzumab

Trastuzumab works by targeting the HER2/neu receptor on cancer cells

Intervention Type DRUG

Pertuzumab

Pertuzumab is a monoclonal antibody which targets the surface of the cells human epidermal growth factor receptor 2 protein (HER2) on the cancer cell, interfering with HER2 causing cancer cell death

Intervention Type DRUG

Other Intervention Names

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Taxol Herceptin Perjeta

Eligibility Criteria

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Inclusion Criteria

* Patients must have Stage II or III (according to AJCC cancer staging manual anatomic staging table, 8th edition) histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 1.5 cm determined by physical exam or imaging (whichever is larger) is required. Patients with inflammatory breast carcinoma (T4d) are NOT eligible.
* Tumors must be HER-2 positive, as assessed by standard local institutional protocol (central testing is not required):

* IHC 3+
* FISH positive based on one of the three following criteria:

Single-probe average HER2 copy number ≥ 6.0 signals/cell; OR

* Dual-probe HER2/CEP17 ratio \<2.0 with an average HER2 copy number ≥ 6.0 signals/cell; OR
* Dual-probe HER2/CEP17 ratio ≥2.0

* ER/PR determination is required. ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol.
* Bilateral breast cancers are allowed as long as both cancers are HER2-positive (as defined in 3.1.2), or the contralateral cancer is a \<1 cm, ER+, and HER2- tumor.
* Patients with multifocal or multicentric disease are eligible as long as all tumor foci that were tested for HER2 status at the local institution are HER2-positive, and at least one tumor focus meets eligibility criteria.
* Breast imaging should include dedicated ultrasound of the ipsilateral axilla. For subjects with a clinically positive axilla based on exam or imaging, a fine needle aspiration or core biopsy procedure will be performed to determine the presence of metastatic disease in the lymph nodes (though lymph node sampling procedure need not be resulted prior to patient's registration on trial, as long as all other eligibility are met).
* Men and women (with any menopausal status) ≥ 18 years of age are eligible.
* ECOG PS 0 or 1.
* Required laboratory values:
* ANC ≥ 1000/mm3
* Hemoglobin ≥ 9 g/dl
* Platelets ≥ 100,000/mm3
* Serum creatinine \< 1.5 x ULN (institutional) OR calculated GFR ≥60mL/min.

-Total bilirubin ≤ 1.5 x ULN (institutional). For patients with Gilbert Syndrome, the direct bilirubin should be within the institutional normal range OR total bilirubin ≤ 2.0 mg/dL.
* AST and ALT ≤ 2.5x ULN (institutional)

* Left ventricular ejection fraction (LVEF) ≥ 50%.
* Premenopausal women must have a negative serum pregnancy test within 14 days of registration, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause.
* Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 7 months after the last dose of study treatment.
* Patients with a history of ipsilateral DCIS are eligible.
* Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy.
* Willing and able to sign informed consent.
* Willing to provide tissue for research purposes

Exclusion Criteria

* Pregnant or nursing women due to the teratogenic potential of the study drugs.
* Active, unresolved infection.
* Receipt of intravenous antibiotics for infection within 7 days prior to registration.
* Uncontrolled hypertension (systolic \>180 mm Hg and/or diastolic \>100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) Class II or higher (see Appendix B), or serious cardiac arrhythmia requiring medication.
* Significant symptoms (Grade ≥ 2) from peripheral neuropathy.
* Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes.
* Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation, or experimental therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No