Utilizing Multiomic Advanced Diagnostics to Identify CDK 4/6 Inhibitor Response Predictors and a Post-treatment Multiomic Signature for Patients With ER+/HER2- Metastatic Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:March 9, 2017
End Date:June 9, 2019

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This is an open-label, multicenter study in patients with metastatic breast cancer who are
candidates for standard first line treatment with palbociclib or ribociclib plus endocrine
therapy. To be eligible, patients must have received no prior chemotherapeutic or hormonal
regimen for metastatic disease. However, patients may still be considered eligible if they
have already started treatment with endocrine therapy (an aromatase inhibitor or fulvestrant)
plus palbociclib or ribociclib for no longer than 4 weeks prior to study enrollment, as long
as they meet all other eligibility criteria. Eligible patients must have had a diagnostic
biopsy of the metastatic lesion no more than 4 months prior to study enrollment and with
sufficient tissue to complete the proposed biomarker analysis. Patients who develop disease
progression within the first 12 months of starting palbociclib or ribociclib plus endocrine
therapy will be eligible for an optional additional tissue biopsy at time of disease
progression to repeat the analysis at time of disease progression and obtain real-time
(10-14-day turn-around) multi-omic data produced under College of American Pathologist
(CAP)/Clinical Laboratory Improvement Amendments (CLIA) development and/or compliant
practices.


Inclusion Criteria:

- Patients must have histologically or cytologically proven diagnosis of adenocarcinoma
of the breast with evidence of locoregionally recurrent or metastatic disease.

- Tumors must be estrogen and/or progesterone receptor positive according to ASCO/CAP
2010 guidelines as either ER or PR ≥ 1% positive nuclear staining by
immunohistochemistry based on local laboratory results.

- Tumors must be HER2 negative as defined according to ASCO/CAP 2013, as HER2 0 - 1+ by
IHC or non-amplified FISH or CISH. If HER2 IHC is 2+, FISH/CISH must be performed and
must not be positive (HER2/CEP17 ratio must be < 2, and HER2 copy number < 6
signals/cell), but otherwise FISH/CISH is not required if IHC is 0 or 1+ by
institutional standards.

- Must be candidates to receive endocrine therapy and palbociclib or ribociclib as
first-line treatment for their advanced disease. Patients will be considered eligible
for study enrollment if they have started on treatment with a standard dose and
schedule of palbociclib or ribociclib and endocrine therapy (aromatase inhibitor or
fulvestrant) as long as they have not started palbociclib or ribociclib treatment for
longer than 4 weeks from time of study enrollment, have sufficient tissue to perform
the proposed tissue analysis and must meet all other eligibility criteria. Endocrine
therapy can be initiated up to 4 weeks prior to starting palbociclib or ribociclib.

- Patients must have measurable disease by RECIST v.1.1 or bone disease as their only
site of disease (with bone lesions confirmed by CT, MRI or bone X-ray).

- No prior treatment with chemotherapy for a diagnosis of locoregionally recurrent or
metastatic breast cancer is allowed.

- Be ≥ 18 years of age

- Have an ECOG score of 0-1

- Postmenopausal women defined as women with:

- Prior bilateral surgical oophorectomy, or

- Medically confirmed post-menopausal status defined as spontaneous cessation of
regular menses for at least 12 consecutive months or follicle-stimulating hormone
(FSH), luteinizing hormone (LH) and estradiol blood levels in their respective
postmenopausal ranges.

- Premenopausal women will be considered eligible for study participation if they are
receiving medical ovarian suppression with luteinizing hormone-releasing hormone
(LHRH) agonists with documented estradiol blood levels in their respective
postmenopausal ranges.

- Archive tumor tissue (obtained from a biopsy or surgical resection of a metastatic
lesion done within 4 months from study enrollment) availability is required for
patient participation. If the available tissue is insufficient for the required
baseline analysis, the patients are given the option to repeat the biopsy for the
purpose of study participation as long as they have not already started palbociclib or
ribociclib.

- Understand and provide written informed consent prior to initiation of any
study-specific procedures.

Exclusion Criteria:

- Lack of archive tumor tissue from a biopsy or surgical resection of a metastatic
lesion done within 4 months of study enrollment. Patients will be given an option to
have a repeated biopsy of a metastatic lesion if they had a diagnostic tumor biopsy
intended for use in the current study that was performed more than 4 months prior to
analysis, or there is insufficient tissue from the initial biopsy to complete the
analysis, as long as they have not started treatment with a CDK 4/6 inhibitor.
Otherwise, the patient will be excluded from the study participation.

- Have symptomatic CNS metastasis. Patients with a history of CNS metastases who have
been treated with whole brain irradiation must be stable without symptoms for 4 weeks
after completion of treatment, with image documentation required, and must be either
off steroids or on a stable does of steroids for ≥ 4 weeks prior to enrollment.

- Have uncontrolled concurrent illness including, but not limited to, ongoing or active
serious infection, symptomatic congestive heart failure, unstable angina pectoris,
unstable cardiac arrhythmias, psychiatric illness, or situations that would limit
compliance with the study requirements or ability to willingly give written informed
consent.
We found this trial at
9
sites
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Andres Forero-Torres, MD
Phone: 205-934-3792
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Monica Mita, MD
Phone: 310-967-2785
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Rachel Yung, MD
Phone: 206-606-6329
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Neelima Denduluri, MD
Phone: 703-208-3192
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fairfax, VA
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Miami, Florida 33136
Principal Investigator: Frances Valdes-Albini, MD
Phone: 305-243-6823
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Miami, FL
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Philadelphia, Pennsylvania 19104
Principal Investigator: Amy Clark, MD
Phone: 215-615-6821
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Philadelphia, PA
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925 Chestnut Street
Philadelphia, Pennsylvania 19107
Principal Investigator: Maysa Abu-Khalaf, MD
Phone: 215-955-0030
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101 Dudley St
Providence, Rhode Island 02905
(401) 274-1100
Principal Investigator: William Sikov, MD
Phone: 401-274-1122
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
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Providence, RI
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