Heating tumors plus drug shows promise in early breast cancer trial
NCT ID NCT03955640
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial tested a combination of hyperthermia (heating the tumor area) and the drug olaparib in 3 patients with breast cancer that had returned on the chest wall. The goal was to see if the combination was safe and could slow tumor growth. The study was terminated early, so results are very limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- olaparib (a PARP inhibitor drug) and hyperthermia treatment (heating the tumor area)
- What this could lead to
- If it works, this could point toward a new combination treatment for breast cancer that has come back on the chest wall.
- What could go wrong
- This was a very small, early-phase trial with only 3 patients, and it was terminated early. The combination may not be safe or effective, and results are too limited to draw conclusions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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3 people
The number who actually took part.
- Started
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May 2019
- Finished
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Aug 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients regardless of estrogen receptor (ER)/progesterone receptor (PR)/HER2 status and have breast cancer recurrence on the chest wall * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses * Hemoglobin \>= 10.0 g/dL with no blood transfusion in the past 28 days (within 28 days prior to administration of study treatment) * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (measured within 28 days prior administration of study treatment) * Platelet count \>= 100 x 10\^9/L (measured within 28 days prior to administration of study treatment) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be =\< 5x ULN (measured within 28 days prior to administration of study treatment) * Patients must have creatinine clearance estimated of \>= 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) * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patients must have a life expectancy \>= 16 weeks * Breast cancer with chest wall disease that is at least 2 cm in size at the greatest dimension * Patients will be eligible for this trial regardless of number of lines of therapy and after adjuvant chemotherapy with recurrence on the chest wall * Patients with hormone receptor positive disease who discontinue endocrine therapy two weeks prior to initiating study treatment are eligible * Body mass index (BMI): 15 to 50 at the time of consent * Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of initiating study treatment and confirmed prior to treatment on day 1 and willingness to use effective contraception during study treatment and for at least 30 days after last dose of study drug. Postmenopausal is defined as: * Amenorrhea for 1 year or more following cessation of exogenous hormonal treatments * Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50 * 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) Exclusion Criteria: * As judged by the investigator, any evidence of non-compliance which in the investigator's opinion makes it undesirable for the patient to participate in the trial * Patients with rapidly progressing disease * Metastatic disease should not be progressing so as to require systemic treatment within 4 weeks of enrollment based on clinical assessment by the investigator * Metastatic disease should not be progressing so as to require palliative treatment within 4 weeks of enrollment based on clinical assessment by the investigator * Other malignancy unless curatively treated with no evidence of disease for \>= 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1, grade 1 endometrial carcinoma * Resting electrocardiogram (EKG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT interval by Fridericia \[QTcF\] prolongation \> 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome * Persistent toxicities caused by previous cancer therapy \>= grade 2, excluding alopecia and neuropathy * Patients with current or previous diagnosis of myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) * Patients with symptomatic uncontrolled brain metastases or spinal cord metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days * Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent * Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication * Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) * Any previous treatment with PARP inhibitor, including olaparib * Subjects with a known hypersensitivity to olaparib or any of the excipients of the product * Patients with a known hypersensitivity to hyperthermia * Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment * Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks * Concomitant use of known strong CYP3A inducers (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents * Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of surgery * Patients with known active hepatitis B or C * Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable outside of 28 days prior to enrollment) * Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT) * Any patient with a known germline BRCA1 or 2 mutation * Participation in another clinical study with an investigational product administered in the last 2 months * Previous enrollment in the present study * Breast feeding women * Involvement in the planning and/or conduct of the study * No radiotherapy, treatment with cytotoxic agents, biologic agents within 3 weeks prior to beginning treatment on this study. Patients must have recovered from the acute toxicities of any prior treatment with cytotoxic drugs to =\< grade 1 (allowance for grade 2 alopecia and neuropathy) in order to be eligible. Patients who underwent post-mastectomy radiation will not be excluded from this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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Other studies related to the condition(s) this trial covers.
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