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New treatment option for Anatomic Stage IV Breast Cancer AJCC v8
Official title 177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer
ClinicalTrials.gov ID: NCT04529044
What this study is testing
What is Lutetium Lu 177 Dotatate?
Lutetium Lu 177 Dotatate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anatomic stage iv breast cancer ajcc v8.
Also referred to as 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate.
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
- This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back (recurrent). 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Life expectancy of \> 6 months, as determined by the investigator
- Ability to understand and the willingness to sign a written informed consent document
- Patients aged \>= 18-100 years old at time of informed consent
- Histologically or cytologically confirmed metastatic breast carcinoma
- Stage IV or recurrent disease with distant metastases
You likely can't join if
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an...
- Individuals in the follow-up phase of a prior investigational study may participate as long as it has been 4 weeks since last dose of the previous...
- Prior external beam radiation therapy to more than 25% of the bone marrow
- Other malignancy unless curatively treated with no evidence of disease for \>= 5 years except: adequately treated non-melanoma skin cancer or...
- Known brain metastases, unless these metastases have been treated and stabilized
- Peptide receptor radionuclide therapy at any time prior to study enrollment
See the full eligibility criteria
Who can join
- Life expectancy of \> 6 months, as determined by the investigator
- Ability to understand and the willingness to sign a written informed consent document
- Patients aged \>= 18-100 years old at time of informed consent
- Histologically or cytologically confirmed metastatic breast carcinoma
- Stage IV or recurrent disease with distant metastases
- Female and male patients with breast cancer will be included in the study
- Participants must have experienced disease progression after at least two lines of standard treatment modalities and/or one prior line of cytotoxic chemotherapy (not just endocrine therapy). Specifically, patients must...
- Participants must have at least one measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v1).1 that is amendable to biopsy
- Confirmed presence of SSTR based on \> 50% of lesions with DOTATATE uptake of 68Ga DOTATATE equivalent to the liver
- Participants must have fully recovered from the acute toxic effects of all prior treatment to grade 1 or less, except alopecia and =\< grade 2 neuropathy which are allowed
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Participant must consent to undergo a pre-treatment screening biopsy for enrollment
- Hemoglobin \>= 8.0 g/dL with no blood transfusion in the past 28 days (measured within 28 days prior to administration of study treatment)
- Absolute neutrophil count (ANC) \>= 2.0 x 10\^9/L (measured within 28 days prior to administration of study treatment)
- Platelet count \>= 75 x 10\^9/L (measured within 28 days prior to administration of study treatment)
- Total bilirubin =\< 3 x institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal (unless liver metastases are present in which case they must be =\< 5 x ULN) (measured within 28 days prior...
- Serum albumin \>= 3.0 g/L, unless prothrombin time or international normalized ratio (INR) value is within the normal range (measured within 28 days prior to administration of study treatment)
- Participants must have serum creatinine =\ = 51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test (measured within 28 days prior to administration of study treatment)
- Female participants of childbearing potential (FOCBP) must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be...
- FOCBP agree to use a highly-effective method of contraception starting with the first dose of study therapy up to 7 months after the last dose of study therapy
- FOCBP are those who are not proven postmenopausal. Postmenopausal is defined as:
- Amenorrheic for \> 24 consecutive months following cessation of exogenous hormonal treatments
- Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50 years of age
- Radiation-induced oophorectomy with last menses \> 1 year ago
- Chemotherapy-induced menopause with \> 1 year interval since last menses
- Surgical sterilization (bilateral oophorectomy or hysterectomy or tubal ligation)
What rules you out
- 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 first dose of 177Lu- DOTATATE...
- Individuals in the follow-up phase of a prior investigational study may participate as long as it has been 4 weeks since last dose of the previous investigational agent or device
- Prior external beam radiation therapy to more than 25% of the bone marrow
- Other malignancy unless curatively treated with no evidence of disease for \>= 5 years except: adequately treated non-melanoma skin cancer or curatively treated in situ cancer of the cervix
- Known brain metastases, unless these metastases have been treated and stabilized
- Peptide receptor radionuclide therapy at any time prior to study enrollment
- Known hypersensitivity to somatostatin analogues or any component of the 68Ga- DOTATATE or 177Lu- DOTATATE formulations
- Patients with uncontrolled infection will not be enrolled until infection is treated per provider discretion
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 6 months prior to enrollment, New...
- Uncontrolled diabetes mellitus as defined by a fasting blood glucose \> 2x ULN
- Any patient receiving treatment with short-acting somatostatin analogs, which cannot be interrupted for both 24 hours before and after the administration of 177Lu, or any patient receiving treatment with long-acting...
- Any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the study; or prior radioembolization; chemoembolization; or external beam radiation therapy (EBRT) to \> 25% of bone marrow, at any time
- Any chemotherapy or targeted therapy within 4 weeks prior to enrollment in the study
- Current spontaneous urinary incontinence making impossible the safe administration of the radioactive study agent
- Any psychiatric illness that prevents patient from informed consent process
- Any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol
- Participant is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. 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.