Estrogen Receptor and/or Progesterone Receptor PositivePhase 2NCT02760030
Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery
A Phase 2 study testing Fulvestrant, Laboratory Biomarker Analysis and Palbociclib in people with Estrogen Receptor and/or Progesterone Receptor Positive and HER2/Neu Negative, run by Ohio State University Comprehensive Cancer Center at 3 sites in United States.
Trial summary
This phase II clinical trial studies how well fulvestrant and palbociclib works in treating older patients with breast cancer that responds to hormone treatment (hormone responsive) that cannot be removed by surgery. Estrogen can cause the growth of estrogen-receptor-positive breast cancer cells. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative, Stage IA Breast Cancer
- What is being tested?
- Fulvestrant, Laboratory Biomarker Analysis and Palbociclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Feb 2017to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Newly diagnosed invasive, estrogen receptor (ER) and/or progesterone receptor (PR)-positive, HER2 negative breast cancer; ER-and/or PR-positive breast cancer is defined by > 10% staining by immunohistochemistry
- Patients must be vulnerable or frail by Balducci Criteria or the patient is refusing breast surgery; vulnerable patients are defined as those with dependence in some instrumental activities of daily living, well controlled co-morbidities, and early symptoms of geriatric syndrome; frail patients are defined as those with three or more co-morbidities, dependence in one or more activities of daily living, or a clinically significant geriatric syndrome; geriatric syndromes include: dementia, delirium, incontinence (fecal and/or urinary), osteoporosis or spontaneous fractures, polypharmacy, visual/hearing impairment, sarcopenia and neglect or abuse
- The patient's refusal to proceed with curative breast surgery has to be documented by the surgeon's and medical oncologist's note
- Absolute neutrophil count (ANC) > 1000/uL
- Platelets > 75,000/L
- Serum creatinine 1.5 X institutional upper limit of normal (ULN)
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- Total bilirubin < 1.5 X ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) 2.5 ULN
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior aromatase inhibitor therapy
- Evidence of distant metastases
- Psychiatric illness, which would prevent the patient from giving informed consent
- Patients receiving strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Case Western University
Cleveland, Ohio, 44106
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
About this study
Official title: Phase II Trial of Primary Endocrine Therapy With Combination of Fulvestrant or an Aromatase Inhibitor and Palbociclib in Elderly Patients With Hormone Responsive Breast Cancer Who Have Inoperable Tumor Or Operable Tumor But Cannot Undergo Surgery Due to Frailty Or Who Refuse Surgery
This phase II clinical trial studies how well fulvestrant and palbociclib works in treating older patients with breast cancer that responds to hormone treatment (hormone responsive) that cannot be removed by surgery. Estrogen can cause the growth of estrogen-receptor-positive breast cancer cells. Hormone therapy using fulvestrant may fight estrogen-receptor-positive breast cancer by blocking the use of estrogen by the tumor cells. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant together with palbociclib may be an effective treatment for hormone responsive breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine treatment failure-free survival (TFFS) rate at one year of combination therapy with pure estrogen antagonist, fulvestrant and cyclin-dependent kinase (CDK) inhibitor, palbociclib as primary endocrine therapy in patients 70 years or older with newly diagnosed non-metastatic hormone receptor positive, human epidermal growth factor receptor 2 (HER-2) negative breast cancer.
SECONDARY OBJECTIVES:
- To determine 1- and 2-year progression free survival. II. To determine safety and toxicity of this combination in the population of patients 70 years or older.
III. To determine whether longitudinal changes in geriatric assessment measures correlate with tolerability of this regimen.
OUTLINE:
Patients receive fulvestrant intramuscularly (IM) on days 1 and 15. Patients also receive palbociclib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 weeks.
- Conditions
- Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Being tested
- Fulvestrant, Laboratory Biomarker Analysis, Palbociclib, Questionnaire Administration, Aromatase Inhibitors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Also called Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780
Given IM
Laboratory Biomarker AnalysisOther
Correlative studies
PalbociclibDrug
Also called Ibrance, PD-0332991, PD-332991
Given PO
Questionnaire AdministrationOther
Correlative studies
Aromatase InhibitorsDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (fulvestrant, palbociclib) | Experimental | Patients receive fulvestrant IM on days 1 and 15. Patients also receive palbociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Fulvestrant; Other: Laboratory Biomarker Analysis; Drug: Palbociclib; Other: Questionnaire Administration; Drug: Aromatase Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure-free survival (TFFS) defined as the proportion of study subjects who remain on treatment from the 1st day of therapy to one year
The proportion of subjects who do not experience treatment failure at one year will be calculated along with the exact binomial confidence interval for the rate.
Measured: 1 year
Secondary outcomes (14)
Change in cognition, as measured by Blessed Orientation-Memory-Concentration Test
Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
Measured: Baseline to up to 12 weeks after removal from study
Change in comorbidities, as measured by the Charlson comorbidity index
Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
Measured: Baseline to up to 12 weeks after removal from study
Change in depression, as measured by the Geriatric Depression Scale
Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
Measured: Baseline to up to 12 weeks after removal from study
Change in functional status, as measured by the ECOG Performance Status Scale
Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
Measured: Baseline to up to 12 weeks after removal from study
Change in functional status, as measured by the History of falls
Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
Measured: Baseline to up to 12 weeks after removal from study
Change in functional status, as measured by the Timed Up test
Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
Measured: Baseline to up to 12 weeks after removal from study
Change in functional status, as measured by the Go Test
Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
Measured: Baseline to up to 12 weeks after removal from study
Change in functional status, as measured by the Instrumental Activities of Daily Living
Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
Measured: Baseline to up to 12 weeks after removal from study
Change in nutritional status, as measured by the Mini Nutritional Assessment
Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
Measured: Baseline to up to 12 weeks after removal from study
Change in social activity and support, as measured by the Medical Outcome Study (MOS)
Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
Measured: Baseline to up to 12 weeks after removal from study
Change in social activity and support, as measured by Social Activity Limitations Survey.
Comprehensive geriatric assessment measures to assess functional independence will be summarized using descriptive statistics such as proportions with confidence intervals and means with standard deviations.
Measured: Baseline to up to 12 weeks after removal from study
Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4
The proportion of adverse events and the exact binomial confidence interval for the rates will also be calculated.
Measured: Up to 12 weeks after removal from study
Progression free survival
Calculated using Kaplan-Meier methods.
Measured: Up to 1 year
Progression free survival (PFS)
Calculated using Kaplan-Meier methods
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start16 Feb 2017
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estrogen Receptor and/or Progesterone Receptor PositiveStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Williams, Ohio State University Comprehensive Cancer Center
- Investigators
- Nicole O Williams, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760030
- Sponsor's protocol ID
- OSU-15266
- Other IDs
- NCI-2016-00146
- Status last verified
- Oct 2025
- First submitted
- 29 Mar 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Primary Endocrine Therapy With Combination of Fulvestrant or an Aromatase Inhibitor and Palbociclib in Elderly Patients With Hormone Responsive Breast Cancer Who Have Inoperable Tumor Or Operable Tumor But Cannot Undergo Surgery Due to Frailty Or Who Refuse Surgery
- ClinicalTrials.gov ID
- NCT02760030
- Acronym / sponsor ID
- OSU-15266
- Conditions
- Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II clinical trial studies how well fulvestrant and palbociclib works in treating older patients with breast cancer that responds to hormone treatment (hormone responsive) that cannot be removed by surgery. Estrogen can cause the growth of estrogen-receptor-positive breast cancer cells. Hormone therapy using fulvestrant may fight estrogen-receptor-positive breast cancer by blocking the use of estrogen by the tumor cells. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant together with palbociclib may be an effective treatment for hormone responsive breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine treatment failure-free survival (TFFS) rate at one year of combination therapy with pure estrogen antagonist, fulvestrant and cyclin-dependent kinase (CDK) inhibitor, palbociclib as primary endocrine therapy in patients 70 years or older with newly diagnosed non-metastatic hormone receptor positive, human epidermal growth factor receptor 2 (HER-2) negative breast cancer.
SECONDARY OBJECTIVES:
- To determine 1- and 2-year progression free survival. II. To determine safety and toxicity of this combination in the population of patients 70 years or older.
III. To determine whether longitudinal changes in geriatric assessment measures correlate with tolerability of this regimen.
OUTLINE:
Patients receive fulvestrant intramuscularly (IM) on days 1 and 15. Patients also receive palbociclib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (fulvestrant, palbociclib) | Experimental | Drug: Fulvestrant, Other: Laboratory Biomarker Analysis, Drug: Palbociclib, Other: Questionnaire Administration, Drug: Aromatase InhibitorsPatients receive fulvestrant IM on days 1 and 15. Patients also receive palbociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed invasive, estrogen receptor (ER) and/or progesterone receptor (PR)-positive, HER2 negative breast cancer; ER-and/or PR-positive breast cancer is defined by > 10% staining by immunohistochemistry
- Patients must be vulnerable or frail by Balducci Criteria or the patient is refusing breast surgery; vulnerable patients are defined as those with dependence in some instrumental activities of daily living, well controlled co-morbidities, and early symptoms of geriatric syndrome; frail patients are defined as those with three or more co-morbidities, dependence in one or more activities of daily living, or a clinically significant geriatric syndrome; geriatric syndromes include: dementia, delirium, incontinence (fecal and/or urinary), osteoporosis or spontaneous fractures, polypharmacy, visual/hearing impairment, sarcopenia and neglect or abuse
- The patient's refusal to proceed with curative breast surgery has to be documented by the surgeon's and medical oncologist's note
- Absolute neutrophil count (ANC) > 1000/uL
- Platelets > 75,000/L
Key exclusion criteria (4 listed)
- Prior aromatase inhibitor therapy
- Evidence of distant metastases
- Psychiatric illness, which would prevent the patient from giving informed consent
- Patients receiving strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FulvestrantAlso: Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780Given IM | Drug | Treatment (fulvestrant, palbociclib) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (fulvestrant, palbociclib) |
| PalbociclibAlso: Ibrance, PD-0332991, PD-332991Given PO | Drug | Treatment (fulvestrant, palbociclib) |
| Questionnaire AdministrationCorrelative studies | Other | Treatment (fulvestrant, palbociclib) |
| Aromatase InhibitorsGiven PO | Drug | Treatment (fulvestrant, palbociclib) |
Primary outcome
Treatment failure-free survival (TFFS) defined as the proportion of study subjects who remain on treatment from the 1st day of therapy to one year
Time frame: 1 year
The proportion of subjects who do not experience treatment failure at one year will be calculated along with the exact binomial confidence interval for the rate.
14 secondary outcomes
Change in cognition, as measured by Blessed Orientation-Memory-Concentration Test
Time frame: Baseline to up to 12 weeks after removal from study
Change in comorbidities, as measured by the Charlson comorbidity index
Time frame: Baseline to up to 12 weeks after removal from study
Change in depression, as measured by the Geriatric Depression Scale
Time frame: Baseline to up to 12 weeks after removal from study
Change in functional status, as measured by the ECOG Performance Status Scale
Time frame: Baseline to up to 12 weeks after removal from study
Change in functional status, as measured by the History of falls
Time frame: Baseline to up to 12 weeks after removal from study
Change in functional status, as measured by the Timed Up test
Time frame: Baseline to up to 12 weeks after removal from study
Change in functional status, as measured by the Go Test
Time frame: Baseline to up to 12 weeks after removal from study
Change in functional status, as measured by the Instrumental Activities of Daily Living
Time frame: Baseline to up to 12 weeks after removal from study
Change in nutritional status, as measured by the Mini Nutritional Assessment
Time frame: Baseline to up to 12 weeks after removal from study
Change in social activity and support, as measured by the Medical Outcome Study (MOS)
Time frame: Baseline to up to 12 weeks after removal from study
Change in social activity and support, as measured by Social Activity Limitations Survey.
Time frame: Baseline to up to 12 weeks after removal from study
Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4
Time frame: Up to 12 weeks after removal from study
Progression free survival
Time frame: Up to 1 year
Progression free survival (PFS)
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole O Williams, MD principal investigator
Ohio State University Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fulvestrant, Laboratory Biomarker Analysis and Palbociclib in people with Estrogen Receptor and/or Progesterone Receptor Positive and HER2/Neu Negative, run by Ohio State University Comprehensive Cancer Center 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 9 inclusion and 4 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: finished, as of the sponsor's last update on 19 Dec 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment failure-free survival (TFFS) defined as the proportion of study subjects who remain on treatment from the 1st day of therapy to one year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.