A PHASE I/II, MULTICENTRE, STUDY COMPRISING A SAFETY RUN-IN OF AZD5363WHEN COMBINED WITH PACLITAXEL IN PATIENTS WITH ADVANCED OR METASTATICBREAST CANCER; FOLLOWED BY A RANDOMISED EXPANSION OF AZD5363 WHENCOMBINED WITH PACLITAXEL VS. PACLITAXEL PLUS PLACEBO IN PATIENTS WITH ERPOSITIVEADVANCED OR METASTATIC BREAST CANCER, STRATIFIED BY PIK3CAMUTATION STATUS (BEECH).

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-092-13
• Lead Sponsor: ASTRAZENECA - PERU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-06
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

1. Informed consent provided
2. Female patients, aged at least 18 years
3. Histological or cytological confirmation of breast cancer
4. World Health Organisation (WHO) performance status 0-1
5. Patients must be able to swallow and retain oral medication.
6. Patients of child-bearing potential should use a contraceptive measures, should not be breast feeding and must have a negative pregnancy test
or Patients must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: Post-menopausal, Documentation of irreversible surgical sterilisation.
7. Patients must not be breast feeding.

Part B. Randomised Expansion:
1. Patients with histological or cytologic diagnosis of ER+ve breast cancer with evidence of relapsed advanced or metastatic disease.
2. Patients who relapsed more than 12 months after completing adjuvant endocrine therapy, or who have not had adjuvant endocrine therapy, must have received prior endocrine therapy for advanced or metastatic disease. Patients who relapsed on adjuvant endocrine therapy, or within 12 months of
completing adjuvant endocrine therapy, may enter the study without prior endocrine
therapy for advanced or metastatic disease
3. Provision of archival tumour sample for PIK3CA mutation testing.
4. Provision of baseline plasma sample for PIK3CA mutation testing.
5. At least one tumour lesion, not previously irradiated, that can be measured accurately at baseline as ≥10 mm.

Exclusion Criteria

1. Involvement in the planning and/or conduct of the study
2. Previous enrolment in the present study.
3. Participation in another clinical study with an investigational product
4. Receipt of any investigational drug within 30 days or 5 half-lives
5. Exposure to agents that inhibit AKT
6. Exposure to agents with PI3K
7. Use of aromatase inhibitors
8. Exposure to potent inhibitors or inducers of CYP3A4
9. Clinically significant abnormalities of glucose metabolism
10. Radiotherapy within 4 weeks before the first dose of IP
11. Last dose of anticancer therapy within 21 days before the first dose of study treatment.
12. Major surgery within 4 weeks before the
first dose of study treatment.
13. Spinal cord compression or brain metastases
14. Severe or uncontrolled systemic diseases
15. Cardiac criteria
16. Unresolved toxicities from prior therapy
17. Nutrophil count <1.5 x 109/L.
18. Platelet count <100 x 109/L.
19. Haemoglobin <9 g/dL
20. ALT >2.5 times ULN
21. AST >2.5 times ULN
22. TB >1.5 times ULN
23. Creatinine >1.5 times ULN
24. Proteinuria >3+
25. Sodium or potassium outside normal range
26. Refractory nausea and vomiting
27. History of hypersensitivity to AZD5363 or
paclitaxel
28. Judgment by the Investigator
29. Current disease or condition known to interfere with metabolism of drugs
30. Chronic Pulmonary diseases
31. Psychiatric diseases
32. Allogeneic bone marrow transplant
33. Immunodeficiency syndrome
34. Blood transfusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified