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Breast CancerPhase 2NCT03874325

Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

A Phase 2 study testing Durvalumab, Anastrozole 1mg and Letrozole 2.5mg in people with Breast Cancer and Hormone Receptor Positive Tumor, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study is to find out if an investigational drug called Durvalumab (MEDI4736) given together with a standard of care aromatase inhibitor drug can help people with breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Durvalumab, Anastrozole 1mg and Letrozole 2.5mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
26 Apr 2019to 6 Jan 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Postmenopausal, defined as meeting criteria per protocol.
  • Clinical T2-T4c, any N, MO by American Joint Committee on Cancer staging, 8th edition, with the goal being definitive surgery after completion of neoadjuvant therapy. Tumor is palpable and its size can be measured bidimensionally by tape, ruler or caliper technique. Largest tumor diameter over 2.0 cm.
  • Pathologic confirmation of invasive breast cancer that is estrogen receptor (ER) positive as defined in the protocol.
  • Invasive breast cancer is Human Epidermal Growth Factor Receptor 2 (HER2) negative as defined in the protocol protocol.
  • Documentation of mammogram and ultrasound [including ductal carcinoma in situ (DCIS) and invasive cancer] of the diseased breast performed within 60 days prior to enrollment. Mammograms for the unaffected contralateral breast is required within 12 months prior to enrollment.
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  • Adequate organ and marrow function, as defined in the protocol.
  • Participants must be willing to undergo a research biopsy at baseline and after one cycle of treatment and to provide tissue obtained at surgery for biomarker and correlative studies.
  • Participants must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • If taking herbal or natural remedies that may have immune modulatory effects, participants must be willing to discontinue use prior to first dose of durvalumab.
  • Body weight over 30 kg.

Who cannot join

  • Participation in another clinical study with an investigational product during the last 4 weeks.
  • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow up period of an interventional study.
  • Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema).
  • An excisional biopsy of this breast cancer. Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration.
  • Surgical axillary staging procedure prior to study entry. Note: Fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted.
  • Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry.
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  • Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
  • History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥ 5 years or adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease or adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ.
  • History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral ductal carcinoma in situ (DCIS) treated with radiotherapy or endocrine therapy or contralateral invasive breast cancer at any time.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection); systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid; or steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). Some exceptions apply.
  • History of primary immunodeficiency.
  • History of allogeneic organ transplant.
  • Known allergy or history of hypersensitivity to durvalumab, or any excipient.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, , or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
  • Known active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved hepatitis B infection are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for hepatitis C RNA. Note: This is applied only to patients with known infection. Screening tests for TB, hepatitis B and C, or HIV are not required.
  • Receipt of live attenuated vaccination within 30 days prior to receiving durvalumab. Note: Patients, if enrolled, should not receive live vaccine while receiving durvalumab and up to 30 days after the last dose of durvalumab.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
  • Participants with uncontrolled seizures.
  • Participants with multi-centric breast cancer (defined as more than one lesion is invasive breast cancer in the same breast separated by ≥ 2 cm of normal breast tissue).
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of investigational product.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase II Trial With Safety Run-in of Neoadjuvant Therapy With an Aromatase Inhibitor in Combination With Durvalumab (MEDI4736) in Postmenopausal Patients With Hormone-Receptor-Positive Breast Cancer

This study is to find out if an investigational drug called Durvalumab (MEDI4736) given together with a standard of care aromatase inhibitor drug can help people with breast cancer.

Being tested
Durvalumab, Anastrozole 1mg, Letrozole 2.5mg, Exemestane 25 MG
Keywords
HR+
Medical subject headings
Breast Neoplasms

What participants receive

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

  • DurvalumabDrug

    Also called MEDI4736

    1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.

  • Anastrozole 1mgDrug

    Also called Arimidex

    Participants will self administer 1 mg anastrozole by mouth daily for 6 months.

  • Letrozole 2.5mgDrug

    Also called Femara

    Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.

  • Exemestane 25 MGDrug

    Also called Aromasin

    Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Study groups in NCT03874325
Study groupRoleWhat they receive
Safety Run In: Durvalumab + Aromatase InhibitorExperimentalParticipants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment.
Receives: Drug: Durvalumab; Drug: Anastrozole 1mg; Drug: Letrozole 2.5mg; Drug: Exemestane 25 MG
Expansion: Durvalumab + Aromatase InhibitorExperimentalParticipants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited.
Receives: Drug: Durvalumab; Drug: Anastrozole 1mg; Drug: Letrozole 2.5mg; Drug: Exemestane 25 MG

What is being measured

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

  1. Rate of Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0

    Modified preoperative endocrine prognostic index (mPEPI) of 0. Total PEPI score assigned to each patient is the sum of the risk points derived from the pathological (pT) stage, lymph node (pN) stage, Ki67 level, and estrogen receptor (ER) status of the surgical specimen. A hazard ratio (HR) in the range of 1-2 receives one risk point; a HR in the 2-2.5 range, two risk points; a HR greater than 2.5, three risk points.

    mPEPI score of 0 indicates a tumor size of 5 cm or less, negative lymph nodes, and Ki67 (proliferation index) of less than or equal to 2.7%. Drug combination will be determined to be efficacious if 7 or more participants achieve an mPEPI of 0.

    Measured: 6 months

Secondary outcomes (2)

  1. Clinical Complete Response (CR)

    Clinical Complete response: Palpable lesion(s) identified at baseline are no longer palpable and there are no new lesion(s) or other signs of disease progression.

    Measured: 6 months

  2. Clinical Partial Response (PR)

    Clinical Partial response: A reduction in the product of the two largest perpendicular diameters of the primary tumor by 50% or more.

    Measured: 6 months

Timeline

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

  1. First posted14 Mar 2019
  2. Study start26 Apr 2019
  3. Primary completion15 Nov 2020
  4. Study completion6 Jan 2021

Why it stopped: lost funding

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
Sequential
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03874325
Sponsor's protocol ID
MCC-19803
Other IDs
ESR-17-13182
Status last verified
May 2022
First submitted
12 Mar 2019
Last updated
31 May 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Soyano Muller AE, Goodridge DN, Mo Q, Whiting J, Khakpour N, Lee MC, Laronga C, Armaghani AJ, Han H, Soliman H, Costa R, Loftus L, Hoover SJ, Kiluk JV, Jameel Z, Czerniecki BJ, Khong HT. Neoadjuvant therapy with an aromatase inhibitor and durvalumab in postmenopausal patients with hormone receptor-positive breast cancer. Breast Cancer Res Treat. 2026 Feb 16;216(1):11. doi: 10.1007/s10549-026-07912-w.

    PubMed 41697438

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab, Anastrozole 1mg and Letrozole 2.5mg in people with Breast Cancer and Hormone Receptor Positive Tumor, run by H. Lee Moffitt Cancer Center and Research Institute 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 11 inclusion and 21 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: stopped early, as of the sponsor's last update on 31 May 2022. 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?

Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0 (time frame: 6 months). 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 NCT03874325, which also lists 1 linked publication.

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 31 May 2022.

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