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Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03281902
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : August 20, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and endocrine therapy. Examine the genetic changes associated with the cancer and comparing the genetic material from the cancer tissue with the genetic material found in the blood may help doctors to develop customized treatment for breast cancer.

Condition or disease Intervention/treatment
Estrogen Receptor Positive HER2/Neu Negative Recurrent Breast Carcinoma Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Procedure: Biopsy Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Study to Evaluate the Role of Tumor Sequencing in Women Receiving Palbociclib for Advanced Hormone Receptor (HR)-Positive, Breast Cancer (PROMISE)
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Ancillary-Correlative (genetic profile analysis)
Patients undergo collection of blood at baseline and on day 1 of each treatment cycle. Patients also undergo tumor biopsy at baseline and 2 months. Biopsy samples are analyzed for genetic profile via next generation sequencing and RNA sequencing. Biopsy samples are also used for the generation of xenograft mice model. Patients are followed up for 3 years.
Procedure: Biopsy
Undergo tumor biopsy
Other Name: Bx

Procedure: Biospecimen Collection
Undergo collection of blood

Other: Laboratory Biomarker Analysis
Correlative studies

Primary Outcome Measures :
  1. Bioinformatics analysis [ Time Frame: Up to 1 year ]
    Identify novel genomic variants and pathways associated with early progression (progression within 12 months) among women with advanced hormone positive breast cancer treated with palbociclib and endocrine therapy

Biospecimen Retention:   Samples With DNA
biopsy samples, DNA and RNA will be extracted and blood draws for collection of plasma, circulating tumor DNA, and circulating tumor cells.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who have disease that is amenable to biopsy and agree to undergo a standard of care core biopsy of recurrent or metastatic breast cancer ,and to collect additional core samples for research purposes.

Inclusion Criteria:

  • Women who have disease that is amenable to biopsy and agree to undergo a standard of care core biopsy of recurrent or metastatic breast cancer, and to collect additional core samples for research purposes
  • Patients must satisfy one of the following criteria for prior therapy:

    • First line setting: No prior endocrine therapy in the metastatic setting with no more than one prior line of chemotherapy in the advanced/metastatic setting
    • Second line setting: Progression on one prior line of endocrine based therapy monotherapy either in the adjuvant or advanced/metastatic setting. Either one or two prior lines of chemotherapy in the advanced setting are allowed
    • Note: Patients receiving bisphosphonate or denosumab therapy prior to registration may continue at the same intervals used prior to study registration
  • First line therapy setting only: Palbociclib and letrozole is recommended for locally advanced or metastatic breast cancer
  • Second line therapy setting only: Palbociclib and fulvestrant is recommended (after progression on first line endocrine therapy) for metastatic breast cancer
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or bone only disease are eligible.

    • Note: Those patients with both non-measurable disease and bone metastases are eligible
    • Note: Patients are not allowed to begin a new systemic anti-cancer therapy during pre-registration with the exception of bisphosphonate or denosumab; palliative radiation is allowed during pre-registration
  • No current evidence of visceral crisis or lymphangitic spread
  • History of central nervous system metastasis are allowed provided they have been treated (i.e., surgery, radiation, and/or radiosurgery) =< 12 weeks prior to registration and have stable neurologic function, including no requirement for medication(s) to control symptoms for at least 2 weeks; Note: patients with known leptomeningeal disease are not eligible
  • Women who are premenopausal must agree to begin or continue an LHRH agonist (goserelin preferred)

    • NOTE: A woman is considered premenopausal if menses has occurred in the last 12 months prior to preregistration and both serum and follicle stimulating hormone (FSH) levels are not in the laboratory?s reference range for postmenopausal females
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0, 1, or 2
  • Able to swallow oral formulation of drugs
  • Signed and dated informed consent document for study participation
  • Willing to submit tissue for required correlative research
  • Histologic confirmation from the pre-registration biopsy of either locally advanced or metastatic breast cancer that is ER-positive and HER2 -negative

    • Note: ER-positive disease is defined as >= 10% nuclear staining; HER2-negative disease per 2013 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, one of the following must apply:

      • 0 or 1+ by immunohistochemistry (IHC) and not amplified by in situ hybridization (ISH)
      • 0 or 1+ by IHC and ISH not done
      • 2+ by IHC and not amplified by ISH or
      • IHC not done and not amplified by ISH
  • Absolute neutrophil count (ANC) >= 1500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 9.0 g/dL
  • Total bilirubin =< 1.5 x upper limit of normal (ULN), (=< 3 x ULN if Gilbert?s disease)
  • Aspartate transaminase (AST) =< 3 x ULN (=< 5 x ULN if liver metastases present)
  • Creatinine =< 1.5 x ULN
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  • Recovered from all toxicities from all prior anticancer therapies

Exclusion Criteria:

  • History of metastatic ER negative or HER2 positive breast cancer
  • Prior treatment in the metastatic setting with everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway
  • Uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Uncontrolled symptomatic cardiac arrhythmia
    • Uncontrolled hypertension (defined as blood pressure > 160/90)
  • Other active second malignancy other than non-melanoma skin cancers =< 3 years of pre-registration; Note: a second malignancy is not considered active if all treatment for that malignancy is completed and the patient has been disease-free for =< 3 years prior to pre-registration
  • Prior hematopoietic stem cell or bone marrow transplantation =< 3 years of pre-registration
  • Known hypersensitivity to palbociclib, letrozole, fulvestrant, goserelin (if applicable) or to any of their excipients
  • Known to be pregnant and planning to continue nursing
  • No tumor identified on biopsy or insufficient tumor cells to obtain ER or HER2 status
  • Any of the following therapies prior to registration:

    • Chemotherapy =< 2 weeks
    • Immunotherapy =< 2 weeks
    • Biologic therapy =< 2 weeks
    • Monoclonal antibodies =< 2 weeks
    • Radiation therapy =< 2 weeks
    • Anti HER2 or other ?targeted? therapy =< 2 weeks
  • The following patients are not eligible

    • Pregnant women
    • Nursing women
    • Women of childbearing potential who are unwilling to employ adequate contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03281902

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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Donald W. Northfelt         
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224-9980
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Alvaro Moreno-Aspitia         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Ciara C. O'Sullivan         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
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Principal Investigator: Ciara O'Sullivan Mayo Clinic
Additional Information:
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Responsible Party: Mayo Clinic Identifier: NCT03281902    
Other Study ID Numbers: MC1634
NCI-2017-01479 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1634 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases