Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/16/2018
Start Date:January 2014
End Date:April 15, 2018

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A Phase 2 Clinical Trial Assessing the Correlation of Early Changes in Standardized Uptake Value (SUV) on Positron Emission Tomography (PET) With Pathological Complete Response (pCR) to Pertuzumab and Trastuzumab in Patients With Primary Operable HER2-Positive Breast Cancer

This research is being done to determine if early changes on a type of imaging procedure
called PET (Positron Emission Tomography) can predict which patients are most likely to
respond to the combination of trastuzumab and pertuzumab when given prior to surgery.

This study will evaluate for the first time the correlation between early changes in SUV and
pCR in men and women with ER-negative, HER2-positive breast cancer receiving trastuzumab and
pertuzumab (PT) pre-operatively. This has not previously been evaluated in patients receiving
antiHER2 therapy alone and as such is novel and potentially practice changing. The results
from this phase 2 biomarker study will be used to plan a randomized study using a predefined
cut point for SUV decline such that the investigators can further attempt to identify a group
of individuals with HER2-positive early breast cancer who do not require cytotoxic
chemotherapy in addition to anti-HER2 agents. This non-invasive biomarker approach will be of
great interest to breast cancer oncologists and patients by facilitating a personalized
approach to managing patients with HER2-positive disease that will undoubtedly spare toxicity
and reduce the costs associated with anti-cancer strategies, without compromising efficacy.

Inclusion Criteria:

- Female and male patients, 18 years old or older

- Histologically proven infiltrating carcinoma of the breast on core needle biopsy that
is: ER/PR ≤10% staining by IHC and HER2 positive - IHC 3+, ISH ≥2.0, or average HER2
copy number ≥6.0 signals per cell or per current ASCO-CAP (American Society of
Clinical Oncology - College of American Pathologists) or NCCN (National Comprehensive
Cancer Network) guidelines. Note: All histological diagnostic material should be
reviewed at enrolling institution as required per local standards.

- Unresected, untreated breast cancer that meets one of the following clinical stages
(see Appendix A): T2, T3, or T4a-c lesion, any N, M0. Note: Patients with inflammatory
breast cancer (T4d) are not eligible. Bilateral cancers are permitted with approval of
the Protocol Chair.

- ECOG performance status 0-1 (Appendix B)

- Adequate organ function as follows:

1. Absolute neutrophil count (ANC) ≥ 1,500/mm3

2. Platelet count ≥ 100,000/mm3

3. Hemoglobin ≥ 10 g/dL

4. Creatinine ≤ 1.5 times the upper limit of normal with creatinine clearance ≥ 50
mL/min using the Modified Cockcroft-Gault method

5. Bilirubin (total) ≤ 1.5 times upper limit normal (with exception of Gilberts
syndrome)

6. AST(SGOT), ALT(SGPT), and alkaline phosphatase ≤ 2 times the upper limit of
normal

- Adequate cardiac function as defined by LVEF ≥ 50% on echocardiogram or multi-gated
acquisition scan (MUGA)

- Able and amenable to baseline and follow-up PET/CT imaging and study-specific biopsy
procedures. Note: If there are any imaging concerns that the patient may not be
suitable for quantitative PET/CT (e.g., a metallic device directly overlies the
breast), discussion with the local and central radiologists is required to confirm
eligibility for the trial. Also, it is expected that subjects have all PET/CT imaging
done on pre-qualified machines for the study; if baseline imaging done on another
machine, please contact the Protocol Chair/designee for guidance prior to confirming
eligibility.

- The patient, if of childbearing potential, is willing to use effective, non-hormonal
contraception while on treatment and for at least 6 months following the last dose of
therapy.

- Patient understands the study regimen, its requirements, risks, and discomforts, and
is able and willing to sign an informed consent form.

Exclusion Criteria:

- Received prior or ongoing local (e.g radiation) or systemic treatment (chemotherapy or
endocrine therapy) for the current breast cancer. Patients who received tamoxifen or
raloxifene or another agent for prevention of breast cancer may be included as long as
the patient has discontinued the treatment at least one month prior to baseline study
biopsy.

- Systemic treatment for prior cancer within the last 5 years, with the exception of
adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or
squamous cell carcinoma of the skin.

- Women who are pregnant or nursing

- Current use of any investigational agents

- Known hypersensitivity to trastuzumab or pertuzumab

- Any medical condition that in the opinion of the investigator puts the patient at risk
of potentially serious complications while on this therapy. Specifically, uncontrolled
hypertension (systolic >150 and/or diastolic >100), unstable angina, congestive heart
failure of any New York Heart Association (NYHA) classification, serious cardiac
arrhythmia requiring treatment (exception: atrial fibrillation, paroxysmal
supraventricular tachycardia), history of myocardial infarction within 6 months of
enrollment.
We found this trial at
10
sites
Baltimore, Maryland 21231
410-955-6190
Principal Investigator: Roisin Connolly, MBBCh
Phone: 410-955-8804
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Birmingham, Alabama 35294
Principal Investigator: Christos Vaklavas, MD
Phone: 205-975-6347
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Birmingham, AL
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Mothaffar F. Rimawi, MD
Phone: 713-798-8874
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Chapel Hill, North Carolina 27599
Principal Investigator: Lisa A. Carey, MD
Phone: 919-843-7044
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Chapel Hill, NC
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Vicente Valero, M.D.
Phone: 713-563-0721
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Indianapolis, Indiana 46202
Principal Investigator: Anna Maria Storniolo, MD
Phone: 317-278-3730
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Indianapolis, IN
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Vandana Abramson, MD
Phone: 615-936-1164
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Rochester, Minnesota 55905
Principal Investigator: Minetta Liu, M.D.
Phone: 855-776-0015
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Rochester, MN
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Seattle, Washington 98109
Principal Investigator: Jennifer Specht, M.D.
Phone: 206-288-1363
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Seattle, WA
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