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A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
Phase 1, PHASE2 trial testing Durvalumab in Triple Negative Breast Neoplasms in 243 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 243 |
| Start date | 21 December 2018 |
| Primary completion | 29 November 2024 |
| Estimated completion | 26 February 2027 |
| Sites | 32 locations across Taiwan, United Kingdom, Poland, South Korea, Canada, United States |
AstraZeneca — full company profile →
Adults 18 to 130, female only, with Triple Negative Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The occurrence of a severe adverse event (meeting pre-specified criteria) that is at least possibly related to durvalumab and/or the novel oncology therapy in 6 DLT-evaluable patients
| Group | Value | 95% CI |
|---|---|---|
| Arm 2 | 0 | |
| Arm 5 | 0 | |
| Arm 6 | 0 | |
| Arm 7 | 0 |
Percentage of evaluable patients with a confirmed Investigator-assessed response of CR (complete response) or PR (partial response). Confirmed response is defined as at least one visit response of CR or PR confirmed by a follow-up scan at least 4 weeks later showing CR or PR.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 | 56.5 | 34.5 – 76.8 |
| Arm 2 | 54.8 | 36.0 – 72.7 |
| Arm 5 | 51.5 | 33.5 – 69.2 |
| Arm 6 | 62.1 | 48.4 – 74.5 |
| Arm 7 | 79.0 | 66.8 – 88.3 |
| Arm 8 | 81.8 | 64.5 – 93.0 |
Time from date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\]) until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression)
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 | 7.3 | 5.4 – 11.3 |
| Arm 2 | 6.4 | 5.4 – 10.3 |
| Arm 5 | 8.3 | 4.8 – 9.3 |
| Arm 6 | 12.6 | 8.4 – 16.3 |
| Arm 7 | 14.0 | 11.0 – 21.1 |
| Arm 8 | 11.2 | 6.9 – 13.8 |
Time from the date of first documented response (which is subsequently confirmed) until the first date of documented progression (PD) or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1). If a patient does not progress following a response, then their DoR will be censored at the last evaluable disease assessment date
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 | 5.6 | 3.75 – 26.12 |
| Arm 2 | 7.9 | 3.98 – 14.59 |
| Arm 5 | 7.8 | 5.42 – 17.77 |
| Arm 6 | 15.2 | 8.44 – NA |
| Arm 7 | 17.6 | 10.51 – 27.27 |
| Arm 8 | 11.5 | 5.16 – NA |
Number of patients with overall survival, the time from date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\]) until the date of death by any cause
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 | 14 | |
| Arm 2 | 18 | |
| Arm 5 | 25 | |
| Arm 6 | 22 | |
| Arm 7 | 28 | |
| Arm 8 | 3 | |
| Arm 1 | 8 | |
| Arm 2 | 9 | |
| Arm 5 | 5 | |
| Arm 6 | 33 | |
| Arm 7 | 30 | |
| Arm 8 | 28 | |
| Arm 1 | 1 | |
| Arm 2 | 4 | |
| Arm 5 | 3 | |
| Arm 6 | 3 | |
| Arm 7 | 4 | |
| Arm 8 | 2 |
Time from date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\]) until the date of death by any cause
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 | 30.0 | 13.0 – NA |
| Arm 2 | 32.6 | 12.9 – 40.0 |
| Arm 5 | 24.8 | 18.6 – 31.9 |
| Arm 6 | 30.3 | 18.8 – NA |
| Arm 7 | NA | 23.2 – NA |
| Arm 8 | NA | NA – NA |
Percentage of patients alive and progression-free at 6 months following date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\])
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 | 56.5 | 34.3 – 73.8 |
| Arm 2 | 52.4 | 33.1 – 68.5 |
| Arm 5 | 65.3 | 46.0 – 79.1 |
| Arm 6 | 75.2 | 61.8 – 84.5 |
| Arm 7 | 79.8 | 67.2 – 88.0 |
| Arm 8 | 78.2 | 59.5 – 89.0 |
Time frame: From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Durva + Pac | Durva + Pac + Capi 400mg Bid | Durva + Pac + Olec 3000mg | Durva + DS-8201a | Durva + Dato-DXd | Durva + Dato-DXd (PD-L1 Hi… |
|---|---|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — | — | — |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — |
| Covid-19 | Infections and infestations | — | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — | — |
| Adrenal insufficiency | Endocrine disorders | — | — | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Hyperthyroidism | Endocrine disorders | — | — | — | — | — | — |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Pathological fracture | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — | — | — | — | — |
| Hypopituitarism | Endocrine disorders | — | — | — | — | — | — |
| Haemorrhage intracranial | Nervous system disorders | — | — | — | — | — | — |
| Bipolar disorder | Psychiatric disorders | — | — | — | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — | — | — | — |
| Calculus urinary | Renal and urinary disorders | — | — | — | — | — | — |
| Renal injury | Renal and urinary disorders | — | — | — | — | — | — |
| Urinary tract obstruction | Renal and urinary disorders | — | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Reaction | System | Durva + Pac | Durva + Pac + Capi 400mg Bid | Durva + Pac + Olec 3000mg | Durva + DS-8201a | Durva + Dato-DXd | Durva + Dato-DXd (PD-L1 Hi… |
|---|---|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — |
| Dry eye | Eye disorders | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Hypothyroidism | Endocrine disorders | — | — | — | — | — | — |
| Covid-19 | Infections and infestations | — | — | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Asthenia | General disorders | — | — | — | — | — | — |
| Amylase increased | Investigations | — | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Keratitis | Eye disorders | — | — | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — | — |
| Neuropathy peripheral | Nervous system disorders | — | — | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — | — | — |
| Breast pain | Reproductive system and breast disorders | — | — | — | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
Most-reported serious reactions: Pneumonitis, Pneumonia, Interstitial lung disease, Febrile neutropenia, Pyrexia, Covid-19, Urinary tract infection, Adrenal insufficiency.
Data from ClinicalTrials.gov NCT03742102 adverse events section.
This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer
8 peer-reviewed publications reference this trial (live from Europe PMC):
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