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Advanced Breast CarcinomaNCT03281902

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

An observational study of Advanced Breast Carcinoma and Locally Advanced Breast Carcinoma, run by Mayo Clinic at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biopsy, Biospecimen Collection and Laboratory Biomarker Analysis
Type of treatment
Surgery or procedure
How many people
68 participants
Where
3 sitesUnited States
Study dates
13 Nov 2017to 4 Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • PRE-REGISTRATION INCLUSION CRITERIA
  • Women who have disease that is amenable to biopsy and agree to undergo a standard of care and /or research biopsy
  • Note: If a standard of care biopsy was recently obtained =< 2 months of pre-registration, eligible patients should agree to a research biopsy of recurrent or metastatic breast cancer prior to the start of protocol treatment 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
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  • 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: The intention to begin palbociclib and letrozole as treatment for locally advanced or metastatic breast cancer
  • Second line therapy setting only: The intention to begin palbociclib and fulvestrant as treatment for metastatic breast cancer (after progression on first line endocrine therapy)
  • Note: Patients who are to receive second line endocrine therapy are allowed to remain on their most recent treatment (tamoxifen or an aromatase inhibitor during the pre-registration period as well as after registration while awaiting insurance approval for the use of palbociclib
  • 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 to lesions that will not be biopsied or used for assessing disease response (target lesions) is allowed during pre-registration
  • No current evidence of visceral crisis
  • History of central nervous system metastasis are allowed provided they have been treated (i.e., surgery, radiation, and/or radiosurgery) >= 12 weeks prior to pre-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 leutinizing hormone releasing hormone (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, blood, stool, and saliva and urine for required correlative research
  • REGISTRATION INCLUSION CRITERIA
  • 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 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 (=< 14 days prior to registration)
  • Platelet count >= 100,000/mm^3 (=< 14 days prior to registration)
  • Hemoglobin >= 9.0 g/dL (=< 14 days prior to registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN), (=< 3 x ULN if Gilbert's disease) (=< 14 days prior to registration)
  • Aspartate transaminase (AST) =< 3 x ULN (=< 5 x ULN if liver metastases present) (=< 14 days prior to registration)
  • Creatinine =< 1.5 x ULN (=< 14 days prior to registration)
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  • Toxicities related to all prior anticancer therapies must have resolved or stabilized, apart from alopecia and peripheral neuropathy; Note: Peripheral neuropathy which has resolved to =< grade 2 toxicity is acceptable

Who cannot join

  • PRE-REGISTRATION 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
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  • 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
  • REGISTRATION EXCLUSION CRITERIA
  • 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
  • Note: Denosumab is exempt from this requirement and can be started at any time prior to initiation of palbociclib and letrozole/fulvestrant without the need to delay protocol therapy
  • Radiation therapy =< 2 weeks
  • Note: Palliative radiation therapy to lesions that will not be biopsied for this study or used for assessing disease response (target lesions) is permitted during the pre-registration period and does not count towards the 2 week window
  • 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
  • Women who have already commenced treatment with an aromatase inhibitor (first line setting) or fulvestrant (second line setting) prior to screening for this study or any prior palbociclib

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: Prospective Study to Evaluate the Role of Tumor Sequencing in Women Receiving Palbociclib for Advanced Hormone Receptor (HR)-Positive, Breast Cancer (PROMISE)

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. Examining 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.

Being tested
Biopsy, Biospecimen Collection, Laboratory Biomarker Analysis
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • Biospecimen CollectionProcedure or surgery

    Undergo collection of blood, urine, stool, and saliva

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT03281902
Study groupRoleWhat they receive
Ancillary-Correlative (genetic profile analysis)Patents undergo collection of blood and stool samples at baseline, 7 days after letrozole monotherapy treatment, and at completion of each cycle, urine samples at baseline and completion of each cycle, and saliva samples at baseline. Patients also undergo collection of blood and urine samples at disease progression. Biopsy samples are analyzed for genetic profile via genome sequencing and RNA sequencing. Biopsy samples are also used for the generation of xenograft mice model.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bioinformatics analysis

    Next-generation sequencing data will be used to identify variants associated with the progression free survival. Pathology analysis will also be performed.

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Ki67 and TK1 changes

    Spearman rank correlation coefficients will be used to assess the relationship between tumor ki67 levels and serum TK1 levels prior to the start of treatment and after 2 months of treatment with palbocic.

    Measured: after 2 months of treatment

  2. Changes in EMT markers (including Vimentin, SLUG and E-cadherin) and tumor infiltrating lymphocytes (TILs) (including CD8, PD-L1, and FOXP3)

    Wilcoxon signed rank tests will be used to assess the fold changes in EMT and TILs after 2 cycles of treatment. Benjamini-Hochberg procedure will be used to control false postive rate.

    Measured: after 2 months of treatment

  3. Changes in serum TK1 levels

    Wilcoxon rank sum tests will be used to assess whether a given element of the CD44high/CD24/low/estrogen receptor (ER) low cancer stem cell-like phenotype differ between those whose TK1 levels fell below 200 after 2 cycles of treatment and those whose TK1 levels remained above 200 after 2 cycles of treatment.

    Measured: After 2 months of treatment

  4. Change in phenotype of Ki67 and serum TK1 levels

    The parameter estimates from fitting a univariate Cox model to these data will be used to obtain an estimate of the hazard ratio and its corresponding 95% confidence interval.

    Measured: After 2 months of treatment

  5. Differences between those with and without a blood draw taken

    A Wilcoxon rank sum test will be used to assess whether baseline TK1 levels differ among those who discontinue treatment prior to the 2 month blood draw and those who do not.

    Measured: After 2 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2017
  2. Study start13 Nov 2017
  3. Primary completion4 Mar 2028 (estimated)
  4. Study completion4 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03281902
Sponsor's protocol ID
MC1634
Other IDs
P50CA168504, 17-002697
Status last verified
Jun 2026
First submitted
7 Sep 2017
Last updated
9 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Breast Carcinoma and Locally Advanced Breast Carcinoma, run by Mayo Clinic at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bioinformatics analysis (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03281902.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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