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Closed (no longer recruiting)Last updated: 9 January 2024

The EMBRACE study: This Phase II trial is evaluating an oral drug (Olaparib) in the treatment of HR-deficient metastatic breast cancer and relapsed ovarian cancer without BRCA1 and BRCA2 mutationsPhase II clinical trial of the PARP inhibitor, olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2

Clinical summary

Summary

Olaparib is the study intervention in this trial. Olaparib (LynparzaTM) is a poly(ADP-ribose) polymerase (PARP) inhibitor. The inactive ingredients are copovidone, colloidal silicon dioxide, mannitol, sodium stearyl fumarate, hydroxypropyl methylcellulose (hypromellose), macrogol 400 (polyethylene glycol 400), titanium dioxide, iron oxide yellow and iron oxide black. It is provided as tablets each containing 100mg or 150mg olaparib for oral administration. administered as 300 mg orally twice daily until disease progression or unacceptable toxicity. Each bottle contains 32 tablets. Patients will be asked to return unused drug and empty drug containers at each return visit for adherence. Olaparib should be commenced within 7 days after registration and will be continued until disease progression or unacceptable toxicity.

Conditions

This trial is treating patients with triple negative breast or ovarian cancers that don't have the BRCA1 or BRCA2 mutation

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

II

Trial Acronym

The EMBRACE study

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Cancer Australia,Australia New Zealand Gynaecological Oncology Group (ANZGOG)

Scientific Title

Phase II clinical trial of the PARP inhibitor, olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2

Eligibility

Inclusion

1. Patients, aged 18 years and older, that are either:
a) men or women with confirmed evidence of metastatic triple negative breast cancer (TNBC) (ER- PR- HER2- by usual site assessment)
OR
b) women with confirmed evidence of relapsed high grade serous ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) or high grade endometrioid ovarian cancer (HGSOC).

2. Patients meeting eligibility criteria 1a (TNBC cohort) must have received anthracycline and/or taxane containing chemotherapy.

3. Patients meeting eligibility criteria 1b (HGSOC cohort) must have received adjuvant platinum containing chemotherapy.

4. Tumour demonstrates genetic or epigenetic evidence of HR deficiency as reported by either by the usual site assessment or on central laboratory testing by the HR deficiency screening.

5. Target lesions according to RECIST v1.1. Patients with only non-target lesions are ineligible. Patients with rising CA125 only are ineligible.

6. Performance status of ECOG 0 - 1.

7. Adequate bone marrow function (e.g. Hb greater than or equal to 100 g/L, platelets greater than or equal to 100 x 109/L, ANC greater than or equal to 1.5 x 109/L), with no blood product transfusions or growth factors received within 28 days.

8. Adequate liver function (e.g. serum bilirubin less than or equal to 1.5 x ULN, ALT/AST less than or equal to 2.5 x ULN unless liver metastases are present in which case AST/ALT less than or equal to 5x ULN).

9. Adequate renal function (e.g. creatinine clearance greater than or equal to 50 mL/min

10. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.

11. Signed, written informed consent.

Exclusion

1. Known carriers of pathogenic or likely pathogenic germline BRCA1/2 mutations. This must be tested prior to study entry, either by the usual site assessment or on central laboratory testing by the HR deficiency screening.
2. Tumour demonstrates pathogenic or likely pathogenic germline BRCA1 or BRCA2 mutations on central laboratory testing.
3. Symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required unless clinically indicated. The patient can receive a stable dose of corticosteroids for brain metastasis, before and during the study, as long as these were started at least 28 days prior to commencing study treatment and provided this is not the only site of measurable disease.
4. First relapse with measurable disease on imaging within 6 months following completion of debulking and chemotherapy (HGSOC cohort only). Interval debulking and pre-operative chemotherapy will be allowed.
5. Any previous platinum chemotherapy for metastatic/relapsed disease, except:
a. TNBC patients where a suitable tumour tissue sample collected following receipt of platinum containing therapy is available. Neoadjuvant platinum containing therapy is also permitted providing screening is undertaken on a post-platinum tumour tissue specimen (e.g. mastectomy or local resection).
b. HGSOC patients with somatic or germline mutations in HRD genes other than BRCA1/2 may receive prior lines of non-study treatment and will be eligible after receiving previous treatment for metastatic/relapsed disease.
6. Participation in another clinical study with an investigational product within 28 days prior to commencing study treatment.
7. Treatment with another anti-cancer treatment within 28 days prior to commencing study treatment.
8. Any previous treatment with a PARP inhibitor, including olaparib.
9. Known hypersensitivity to any excipients of olaparib.
10. Patients who are unable to swallow orally administered medication or have gastrointestinal disorders likely to interfere with absorption of the study medication (e.g. including but not limited to partial bowel obstruction or chronic malabsorption syndrome, Crohn’s disease and ulcerative colitis).
11. Blood transfusions within 28 days prior to commencing study treatment. Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, for timing refer to inclusion criteria no.7)
12. Patients with myelodysplastic syndrome/acute myeloid leukaemia. Patients with a peripheral blood smear with features suggestive of MDS/AML are not eligible.
13. Uncontrolled seizures.
14. Known interstitial lung disease/pneumonitis.
15. Receiving the following classes of inhibitors of CYP3A4 (see Section 5 for guidelines and wash out periods).
- Azole antifungals
- Macrolide antibiotics
- Protease inhibitors
16. Current toxicities (CTCAE = grade 2) caused by previous cancer therapy (except alopecia or peripheral neuropathy).
17. Not recovered from the effects of major surgery, if the surgery was within 14 days prior to starting study treatment.
18. Life expectancy of less than 3 months.
19. History of another malignancy within 3 years prior to registration. Patients with or who:
a) curatively treated earlystage cervical carcinoma or carcinoma in situ,
b) non-melanomatous carcinoma of the skin,
c) superficial bladder tumours (T1a [Non-invasive tumour], and Tis [Carcinoma in situ]),
d) treated thyroid papillary cancer,
e) are disease-free from other malignancies for = 3 years prior to registration
are eligible for this study.
20. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
21. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
22. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use two highly effective means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a double barrier method of contraception (see Appendix 3 for details).
23. Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
24. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
25. Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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