Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02598427 : Intrathecal Pertuzumab and Trastuzumab in Patients With New Untreated Asymptomatic or Low Symptomatic Brain Metastasis in HER2 Positive Breast Cancer
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- HER2 positive by 2013 ASCO-CAP guidelines (IHC 3+ and/or FISH positive; IHC 2+ HER2
patients are eligible with reflex FISH positive testing with the ratio ? 2.0) breast
cancer patients with untreated asymptomatic or minimally symptomatic brain metastasis
by MRI. There is no upper or lower limit to the size or number of brain metastases.

- Patients can have previous brain metastasis that was completely surgically resected if
the previously resected lesion is at least 1 cm from target lesion(s) for this study.
The location of the previous resection cavity is determined by the post-resection MRI.

- Patients can have previous brain metastasis that was treated with stereotactic
radiosurgery (SRS) if the previously treated lesion is at least 1cm from the target
lesion(s) for this study. The location of the previous SRS treatment location is
determined by the SRS MRI.

- Patients can be on steroids as long as the dose has been stable for ? 7 days

- No limitations on prior systemic or intrathecal therapies.

- There are no restrictions on systemic therapy at enrollment.

- Negative serum pregnancy test for pre-menopausal women and women within 12 months from
the onset of menopause.

- Sexually active women of childbearing potential must commit to 2 methods of
contraception while enrolled on the trial and continue using contraceptives for at
least 7 months post study drug administration. Sexually active men must commit to 1
method of contraception while enrolled and for 7 months after. Hormonal contraceptives
such as birth control pills, patches, implants or injections are not allowed in
patients who are HR+.

- Life expectancy ? 8 weeks

- Laboratory criteria: normal renal function: creatinine < 1.5 x upper limit of normal
(ULN)), liver function: bilirubin ? 1.5 x ULN, transaminases ? 2 x ULN, except in
known hepatic disease, wherein may be ? 5 x ULN, and blood counts: WBC ? 2.0,
Neutrophils ?1500, platelets ?100,000, Hemoglobin ? 10.

- LVEF (left ventricular ejection fraction) ? 50%

- Karnofsky performance status (KPS) ? 50

- Age ? 18 years

- Patients must have the ability to give informed consent.

- Patients must sign an informed consent form.

Exclusion Criteria:

- No seizures, focal weakness of any extremity (by neurologic exam), or stroke symptoms
in the past month.

- No history of prior whole brain radiation.

- No history of lumbar surgery or other pre-existing spinal conditions that would
preclude frequent, safe, reliable lumbar punctures.

- No history of serious cardiac arrhythmia or EF < 50%.

- Systemic sites of disease need to be stable on systemic therapy based on the most
recent (within 12 weeks) staging scans.

- Radiation while on study is not allowed EXCEPT to a localized region for pain control.

- No history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ
of the cervix) unless the patient has been in remission and off all other cancer
therapy for at least 3 years.

- Patients should have no significant psychiatric illness or medical illness that would
preclude the ability to comply with the protocol.

- Patients may not be pregnant or breastfeeding.

- No known hypersensitivity to trastuzumab or pertuzumab.

- Symptomatic intrinsic lung disease or extensive tumor involvement in the lungs
resulting in dyspnea at rest.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02598427      |      Link to official Clinicaltrials.gov listing
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