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New treatment option for Breast Cancer
Official title A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
ClinicalTrials.gov ID: NCT07205822
What this study is testing
What is Dato-DXd?
Dato-DXd is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as IMP administration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must be ≥ 18 years (and above legal age) at the time of screening.
- Inoperable or metastatic HR-positive, HER2 IHC 0 breast cancer (per ASCO/CAP guidelines, on local laboratory results); ie, is documented as...
- Progressed on and not suitable for further endocrine therapy per investigator assessment.
- ECOG performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to the first dose of study intervention.
- Minimum life expectancy of 12 weeks at screening.
You likely can't join if
- As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases and...
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first...
- Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline. Note: participants may be...
- Chemotherapy-induced neuropathy
- Fatigue
- Residual toxicities from prior immunotherapy treatment: Grade 1 or Grade 2 endocrinopathies, which may include but are not limited to...
See the full eligibility criteria
Who can join
- Participant must be ≥ 18 years (and above legal age) at the time of screening.
- Inoperable or metastatic HR-positive, HER2 IHC 0 breast cancer (per ASCO/CAP guidelines, on local laboratory results); ie, is documented as HR-positive (either ER and/or PgR positive [ER or PgR ≥ 1%]) and HER2 IHC 0...
- Progressed on and not suitable for further endocrine therapy per investigator assessment.
- ECOG performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to the first dose of study intervention.
- Minimum life expectancy of 12 weeks at screening.
- Provision of acceptable tumour sample (no more than 6 weeks old) prior to the first dose of study intervention or retrospectively as defined in the Laboratory Manual and the Diagnostic Testing Manual
- Participants must have measurable disease as per RECIST 1.1 or evaluable disease. Lesions that will be subject to mandatory biopsy before, during, and after the dosing cannot be considered as TLs as per RECIST...
- Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention.
- Haemoglobin ≥ 9.0 g/dL (red blood cell/plasma transfusion is not allowed within 1 week prior to screening assessment).
- Absolute neutrophil count ≥ 1.5×109/L (granulocyte colony stimulating factor administration is not allowed within 1 week prior to screening assessment).
- Platelet count ≥ 100×109/L (platelet transfusion is not allowed within 1 week prior to screening assessment).
- Serum albumin ≥ 2.5 g/dL.
- TBL ≤ 1.5 × ULN or ≤ 3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinaemia).
- Except in the setting of HBV, ALT and AST ≤ 2.5 × ULN; for participants with hepatic metastases, ALT and AST ≤ 5 × ULN. See Exclusion Criterion 8 for requirements in the setting of HBV.
- Calculated CrCL ≥ 30 mL/min as determined by Cockcroft Gault (using actual body weight).
- Male and/or female assigned at birth, inclusive of all gender identities.
- Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies; (a) Male participants: (i) Use of...
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this CSP.
- All races, genders, and ethnic groups are eligible for this study.
What rules you out
- As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases and significant cardiac or psychological conditions), history of allogenic...
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence...
- Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline. Note: participants may be enrolled with some chronic, stable Grade 2 toxicities (defined as no...
- Chemotherapy-induced neuropathy
- Fatigue
- Residual toxicities from prior immunotherapy treatment: Grade 1 or Grade 2 endocrinopathies, which may include but are not limited to hypothyroidism/hyperthyroidism, Type I diabetes, hyperglycaemia, adrenal...
- Spinal cord compression or brain metastases (unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 2 weeks prior to the first dose of study intervention)...
- Leptomeningeal carcinomatosis or metastasis.
- Has significant third-space fluid retention (eg, ascites or pleural effusion) and is not amenable for required repeated drainage.
- Clinically significant corneal disease.
- Has active or uncontrolled hepatitis B or C virus infection. Participants are eligible if they:
- Have been curatively treated for HCV infection as demonstrated clinically and by viral serologies
- Have received HBV vaccination with only anti-HBs positivity and no clinical signs of hepatitis
- Are HBsAg- and anti-HBc+ (ie, those who have cleared HBV after infection) and meet conditions i-iii of criterion 'd' below:
- Are HBsAg+ with chronic HBV infection (lasting 6 months or longer) and meet conditions i-iii below: (i) HBV DNA viral load \< 2000 IU/mL (ii) Have normal transaminase values or, if liver metastases are present, abnormal...
- Known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥ 350, no history of AIDS defining...
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections (participants with localised fungal infections of skin or...
- Known to have active tuberculosis infection (clinical evaluation that may include clinical history, physical examination, and radiographic findings, or tuberculosis testing in line with local practice).
- Resting ECG with clinically abnormal findings.
- Uncontrolled or significant cardiac disease including:
- Myocardial infarction or uncontrolled/unstable angina within 6 months before the first dose of study intervention.
- Congestive heart failure (New York Heart Association Class II to IV).
- Uncontrolled hypertension (resting systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg).
- Cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (NCI CTCAE Grade 3), symptomatic or uncontrolled atrial...
- History of non-infectious ILD/pneumonitis, including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Has severe pulmonary function compromise.
- Prior exposure to the following anticancer therapies:
- Any TROP2-targeted therapy.
- Any treatment (including ADC) containing a chemotherapeutic agent targeting topoisomerase I.
- Any chemotherapy in the metastatic setting.
- Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period of \> 14 days before the first dose of study intervention.
- Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, tumour embolisation, or monoclonal antibodies ≤ 3 weeks [for small molecule targeted agents: ≤ 2 weeks or...
- Any concurrent anticancer treatment with the exception of bisphosphonates, denosumab for the treatment of bone metastases. Concurrent use of hormonal therapy for non cancer related conditions (eg, HRT) is allowed.
- Received prior radiotherapy to the chest within 4 weeks of the start of study intervention or has ongoing radiation-related toxicities requiring corticosteroids.
- Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or with wide field of radiation to chest or to more than 30% of the bone marrow within ≤ 4 weeks prior to the first dose of study intervention.
- Curative radiotherapy; however, palliative radiotherapy for optimal symptom control or pain management is allowed.
- Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications \> 10 mg/day of prednisone or equivalent, except for managing AEs; inhaled steroids, intra-articular steroid...
- Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
- Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks (unless the safety profile is known prior to the first dose of study intervention)...
- Participants with a known history of severe hypersensitivity reactions to either the drug or inactive excipients (including but not limited to polysorbate 80) of Dato-DXd.
- Participants with a known history of severe hypersensitivity reactions to other monoclonal antibodies.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- Previous enrolment in the present study.
- For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding or planning to become pregnant.
- Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention.
- Participants for whom the use of steroid-containing mouthwash in contraindicated.
The study team makes the final eligibility decision.
Where it's taking place
- Largo, Florida, United States
- Fort Wayne, Indiana, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Houston, Texas, United States
- Puyallup, Washington, United States
- Beijing, China
- Changsha, China
- Guangzhou, China
- Linyi, China
- Shandong, China
- Wuhan, China
- Zhengzhou, China
- Clermont-Ferrand, France
- La Roche-sur-Yon, France
- Montpellier, France
- Paris, France
- Pierre-Bénite, France
- Aviano, Italy
- Florence, Italy
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Largo, Florida, United States; Fort Wayne, Indiana, United States; Omaha, Nebraska, United States; New York, New York, United States; Houston, Texas, United States; Puyallup, Washington, United States and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.