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Female Breast CarcinomaPhase 2NCT02942355

Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer

A Phase 2 study testing anastrozole and Palbociclib in people with Female Breast Carcinoma and Breast Cancer, run by Wake Forest University Health Sciences at 1 site 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 is an open-label, pilot study designed to evaluate the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after first-line chemotherapy in postmenopausal patients with HR-positive, HER2-negative… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Female Breast Carcinoma, Breast Cancer
What is being tested?
anastrozole and Palbociclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
7 Dec 2016to 30 Jun 2028
Phase
Phase 2
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

Who may be able to join

  • Are 18 years of age or older, who are either:
  • Postmenopausal, as defined by at least one of the following criteria:
  • Age greater than or equal to 60 years;
  • Age less than 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and serum estradiol, FSH and LH level within the laboratory reference range for postmenopausal females;
  • Documented bilateral oophorectomy;
  • Medically confirmed ovarian failure OR premenopausal or perimenopausal, i.e., not meeting the criteria for being postmenopausal.
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  • Premenopausal or perimenopausal women can be enrolled if amenable to be treated with an LHRH agonist. Patients must have commenced treatment with an LHRH agonist at least 4 weeks prior to start of study treatment.
  • Histologically or cytological confirmed diagnosis of breast cancer with evidence of metastatic disease. Locally advanced disease not amenable to resection is eligible.
  • Documentation of ER-positive and, or PR-positive tumor based on most recent tumor biopsy (unless bone-only disease). ER and PR assays are considered positive if there is at least 1 percent positive in the tumor sample.
  • Documentation of HER2-negative tumor based on most recent tumor biopsy. Tumor must not demonstrate overexpression of HER2 by either IHC (immunohistochemistry) or in-situ hybridization (ISH).
  • No previous treatment for metastatic disease for Cohort A.
  • For Cohort A: previous treatment with endocrine therapy in the adjuvant or neoadjuvant setting is allowed
  • For Cohort B: only first-line chemotherapy (can be single-agent or a combination regimen) for metastatic disease with response (defined as a complete response or partial response by RECIST version 1.1, or stable disease for six months or more from this regimen) and chemotherapy discontinued for 21 days is allowed; patients may have received prior systemic therapy in the adjuvant or neoadjuvant setting.
  • For Cohort A, measurable disease as defined by RECIST version 1.1, or bone-only disease prior to start of study treatment. Patients with bone-only metastatic cancer must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by CT or MRI. Patients with bone-only disease who have blastic-only metastasis are not eligible. Tumor lesions previously irradiated or subjected to other loco regional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented. For Cohort B, measurable disease as defined by RECIST version 1.1, or evaluable disease.
  • Patient has archival tumor tissue available that is formalin-fixed and paraffin-embedded. Biopsy sample taken at the time of presentation with recurrent or metastatic disease is recommended.For patients who do not have archival tissue, tissue from a fresh biopsy should be obtained prior to study treatment initiation, if it can be safely attained using local anesthesia only. One exception is those patients with bone-only disease for whom provision of previous archival tissue would be acceptable. Serial fresh tumor tissue samples will be collected in patients with lesions amenable for a biopsy who consent to such a procedure.
  • ECOG performance status 0, 1 or 2.
  • Must have normal organ and marrow function as defined below:
  • Hematologic: Absolute neutrophil count greater than or equal to 1,500/mcL;
  • Platelets greater than or equal to 100,000/mcL; Hemoglobin greater than or equal to 9 g/dL.
  • Renal: Serum creatinine less than or equal to 1.5X ULN or Measured or calculated creatinine clearance (CrCl) greater than or equal to 60 mL/min for subject with creatinine levels > 1.5X ULN [CrCl should be calculated per institutional standard; GFR can also be used in place of creatinine or CrCl]
  • Hepatic: Total bilirubin less than or equal to 1.5X ULN; AST(SGOT)/ALT(SGPT) less than or equal to 3X ULN (less than or equal to 5X ULN if liver metastases present); Alkaline phosphatase less than or equal to 2.5X ULN (less than or equal to 5X ULN if liver or bone metastases present)
  • Able to swallow and retain oral medication per the Investigator.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Prior treatment with any CDK inhibitor
  • Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
  • Use of food or drugs known to be potent CYP3A4 inhibitors and drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited Medications Section)
  • Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 3 weeks before treatment.
  • Any of the following within 6 months prior to study consent: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or more, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
  • Impairment of gastro-intestinal function or GI disease that may significantly alter the absorption of palbociclib, such as history of GI surgery which may result in intestinal blind loops and patients with clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease or diarrhea of CTCAE Grade > 1.
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  • Prior hematopoietic stem cell or bone marrow transplantation.
  • Known hypersensitivity to anastrozole.
  • Known human immunodeficiency virus infection.
  • Other severe acute or chronic medical or psychiatric condition, that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
  • Participation in other studies involving investigational drug(s) within 4 weeks before treatment initiation in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

Other trials in United States

About this study

Official title: Pilot Trial of Anastrozole and Palbociclib as First-Line Therapy and as Maintenance Therapy After First Line Chemotherapy in Hormone Receptor Positive, HER2-Negative Postmenopausal Metastatic Breast Cancer

This is an open-label, pilot study designed to evaluate the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after first-line chemotherapy in postmenopausal patients with HR-positive, HER2-negative metastatic breast cancer. Pre- and perimenopausal women must receive therapy with an LHRH agonist. The LHRH agonist will be by choice for an approved LHRH agonist administered according to its respective prescribing information. Following informed consent and eligibility check, subjects will be enrolled to either Cohort A or Cohort B.

Read the detailed description

A total of 40 subjects will be enrolled over an enrollment period of 18-24 months. The study is planned to enroll up to 25 patients in Cohort A (upfront) and 15 patients in Cohort B (maintenance). Subjects will be recruited through Levine Cancer Institute locations and through referrals. Women of any race or ethnic origin who meet the study criteria may participate in this clinical trial. Males will not be eligible for this study. Breast cancer in men is rare and the efficacy of aromatase inhibitors in males is limited. Children are not included in this clinical trial because the effects of palbociclib are not known in the pediatric population, but may be eligible for other pediatric trials.

Medical subject headings
Breast Neoplasms

What participants receive

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

  • anastrozoleDrug

    Also called Arimidex

    Anastrozole by mouth daily

  • PalbociclibDrug

    Also called Ibrance

    Palbociclib by mouth daily days 1-21 every 28 days

Study groups in NCT02942355
Study groupRoleWhat they receive
Cohort A: First-line therapyExperimentalAnastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle
Receives: Drug: anastrozole; Drug: Palbociclib
Cohort B: Maintenance therapyExperimentalAnastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle
Receives: Drug: anastrozole; Drug: Palbociclib

What is being measured

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

  1. Number of participants with neutropenia that leads to permanent treatment discontinuation

    Determined for each subject as a binary variable indicating whether or not the participant experienced any neutropenic adverse event (according to NCI Common Terminology for Adverse Events version 4.0) that leads to permanent treatment discontinuation

    Measured: From enrollment to treatment discontinuation; participants remain on treatment until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision. Assessed for approximately 4 years.

Secondary outcomes (4)

  1. Overall Survival (OS)

    Defined as the duration from start of first line metastatic chemotherapy to the date of death from any cause. Participants who are alive or lost to follow up at the time of the analysis will be censored at the last known date they were alive.

    Measured: From date of treatment start to date of death, or censored as described; assessed for approximately 4 years

  2. Progression Free Survival (PFS)

    PFS is defined as the duration of time from the start of first line metastatic chemotherapy to first occurrence of either progressive disease (PD) or death. PD must be objectively determined per RECIST 1.1 criteria, where progression date is date of the radiologic assessment that identified PD. If subject died without documented PD, progression date will be death date. For surviving subjects who do not have PD, PFS will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial PFS event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.

    Measured: From treatment start date to date of progression/death, or censored as described; assessed for approximately 4 years.

  3. Number of participants with an objective response

    Objective response will be determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of complete response (CR) or partial response (PR) as determined by RECIST 1.1 response criteria. A CR is indicated by disappearance of all target and non target lesions. A PR is indicated by >=30% decrease in sum of longest diameter of target lesions with baseline as reference.

    Measured: From enrollment to best response while on study treatment; participants remain on treatment until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision. Assessed for approximately 4 years.

  4. Number of participants with clinical benefit

    Clinical benefit will be determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of complete response (CR), partial response (PR), or stable disease (SD) for >=6 months as determined by RECIST 1.1 response criteria. A CR is indicated by disappearance of all target and non target lesions. A PR is indicated by >=30% decrease in sum of longest diameter of target lesions with baseline as reference. SD is indicated by neither sufficient shrinkage to qualify for PR nor sufficient growth from nadir (>=20%) to indicate progression.

    Measured: From enrollment to best response while on study treatment; participants remain on treatment until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision. Assessed for approximately 4 years.

Timeline

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

  1. First posted24 Oct 2016 (estimated)
  2. Study start7 Dec 2016
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 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
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02942355
Sponsor's protocol ID
IRB00081369
Other IDs
00017766, LCI-BRE-H2N-ANPA-001
Status last verified
Jul 2026
First submitted
19 Oct 2016
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anastrozole and Palbociclib in people with Female Breast Carcinoma and Breast Cancer, run by Wake Forest University Health Sciences at 1 site 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 23 inclusion and 11 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

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?

Number of participants with neutropenia that leads to permanent treatment discontinuation (time frame: From enrollment to treatment discontinuation; participants remain on treatment until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision. Assessed for approximately 4 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 NCT02942355.

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 24 Jul 2026.

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