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Breast NeoplasmsPhase 1/2NCT03594396

Window of Opportunity Trial of Neoadjuvant Olaparib and Durvalumab for Triple Negative or Low ER+ Breast Cancer

A Phase 1/2 study testing Olaparib and Durvalumab in people with Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.

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

Window of Opportunity Trial of Olaparib and Durvalumab (MEDI4736) before Standard Neoadjuvant Chemotherapy for Stage II/III Triple Negative or Low ER+ Breast Cancer Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
Olaparib and Durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteSouth Korea
Study dates
29 Jun 2018to 31 Dec 2026
Phase
Phase 1/2
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Nineteen years of age or older on the day of signing informed consent.
  • Willing and able to provide written informed consent for voluntary participation in the trial.
  • Has previously untreated, clinical stage II/III triple negative breast cancer (TNBC) or low estrogen receptor (ER) tumor where ER is expressed in ≤10% tumor cells) .
  • Willing to provide biopsies from the primary tumor or lymph nodes at screening to the central laboratory and agrees to have a core needle biopsy or incisional or excisional tumor biopsy after 14 days and 28 days of olaparib treatment (before and after durvalumab treatment) if tumor biopsy is feasible as judged by the investigator.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for >1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry and agree to use contraception if they or their partner are of reproductive potential.
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  • Has adequate organ function.
  • Hemoglobin ≥ 10.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (> 1500 per mm3)
  • Platelet count ≥ 100 x 109/L (>100,000 per mm3)
  • Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
  • AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN unless due to Gilbert's syndrome
  • INR/PT/APTT each ≤ 1.5 x ULN
  • TSH within normal limits
  • Serum creatinine < 1.5 x ULN or serum creatinine CL > 51 mL/min by the Cockcroft-Gault formula (Cockroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
  • Subject is 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.

Who cannot join

  • Underweighted populations - ≤30kg
  • Has evidence of metastatic breast cancer, inflammatory breast cancer, or concurrent bilateral invasive breast cancer where ER is expressed in >10% tumor cells.
  • (Note) Patients with bilateral invasive breast cancers can be enrolled if both tumors are TNBCs, including low estrogen receptor (ER) tumor where ER is expressed in ≤10% tumor cells.
  • Has another malignancy within the last 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and thyroid cancer that has undergone potentially curative surgery, or in situ cervical cancer.
  • (Note) These patients should be consulted to the principal investigator for a case-by-case decision before enrollment.
  • Has received prior chemotherapy, targeted therapy, radiation therapy, immunotherapy that targets immune checkpoints, co-stimulatory or co-inhibitory pathways for T cell receptors within the past 12 months.
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  • Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
  • Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug.
  • Has received a live vaccine within 30 days of the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine up to 30 days after the last dose of IP.
  • Has an active autoimmune disease or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]) that has required systemic treatment in past 2 years. The followings are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment.
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 3 years may be included but only after consultation with the principal investigator.
  • Patients with celiac disease controlled by diet alone may be included but only after consultation with the principal investigator.
  • Has a diagnosis of immunodeficiency
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
  • Systemic corticosteroid at physiologic dose not to exceed 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
  • Has a known history of Human Immunodeficiency Virus (HIV).
  • Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B, hepatitis C, or human immunodeficiency virus (HIV, positive HIV 1 or 2 antibodies). Active hepatitis B virus (HBV) infection is defined by a positive HBV surface antigen (HBsAg) and positive titer for HBV DNA.result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core IgG antibody and the absence of HBsAg, deoxyribonucleic acid [DNA] negative) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)..
  • Has evidence of active, non-infectious pneumonitis.
  • Has history of pneumonitis requiring treatment with steroids or history of interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Has significant cardiovascular disease, such as: History of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months; Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA class III or IV
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  • Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.
  • Has a known hypersensitivity to the components of the study drug or its analogs.
  • Concurrent use of any medications or substances that are strong inhibitors of cytochrome P450 (CYP) 3A (CYP3A), such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir, or strong inducers of CYP3A4. Dihydropyridine calcium-channel blockers are permitted for management of hypertension.
  • Previous allogenic bone marrow transplant or (single) umbilical cord blood transplantation
  • Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, as long as not received within 28 days of start of treatment.
  • Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction within 14 days of treatment
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  • Subjects with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
  • Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • History of leptomeningeal carcinomatosis

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Window of Opportunity Trial of Olaparib and Durvalumab (MEDI4736) Before Standard Neoadjuvant Chemotherapy for Stage II/III Triple Negative or Low ER+ Breast Cancer

Window of Opportunity Trial of Olaparib and Durvalumab (MEDI4736) before Standard Neoadjuvant Chemotherapy for Stage II/III Triple Negative or Low ER+ Breast Cancer

Read the detailed description

This is a non-randomized, prospective, open label, window pilot study to evaluate the change of tumor biology after olaparib and durvalumab treatment by serial biopsy of breast cancer.

Being tested
Olaparib, Durvalumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • OlaparibDrug

    Also called Lynparza

    Olaparib 300mg bid will be given on days 1-28 days without rest.

  • DurvalumabDrug

    Also called IMFINZI, MEDI4736

    A fixed dose of durvalumab 1500 mg is given via IV infusion on Day 15.

Study groups in NCT03594396
Study groupRoleWhat they receive
MEDIOLAExperimentalPrior to the start of study medication, tumor tissue and blood will be collected as baseline. Olaparib 300mg bid will be started after the collection of tumor and blood. Olaparib will be given on days 1-28 days without rest. Tumor tissue and blood will be collected on day 14 before administration of durvalumab, to see the change in biomarkers after 2 weeks of olaparib treatment. After the acquisition of tumor and blood, durvalumab will be given in a fixed one dose of 1.5 gram on day 15. On day 29, there will be a third acquisition of tumor and blood, to see the change in biomarkers after combination treatment of olaparib and durvalumab. Tumor response will also be evaluated according to RECIST criteria version 1.1 based on CT.
Receives: Drug: Olaparib; Drug: Durvalumab

What is being measured

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

  1. The changes of tumor biology

    The changes of tumor biology detected by serial biopsy of breast cancer before and after olaparib and durvalumab (exploratory serial biopsy study)

    Measured: 28 days

Secondary outcomes (4)

  1. pathological complete response

    Number of participants with a pathological complete response (ypT0/Tis, ypN0).

    Measured: 7 months

  2. Response rate

    Response rate by RECIST v.1.1

    Measured: 7 months

  3. Treatment-related adverse events as assessed by CTCAE v4.0

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 7 months

  4. Adverse events of special interest and immune-mediated adverse events

    Adverse events of special interest and immune-mediated adverse events

    Measured: 7 months

Timeline

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

  1. First posted20 Jul 2018
  2. Study start29 Jun 2018
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03594396
Sponsor's protocol ID
S1709-101-888
Status last verified
Oct 2026
First submitted
6 Jul 2018
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Olaparib and Durvalumab in people with Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.

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 16 inclusion and 38 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 19 Oct 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 South Korea. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The changes of tumor biology (time frame: 28 days). 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 NCT03594396.

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 Oct 2026.

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