Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer Clinical Trial in New York, NY

Q: Is NCT04997993 recruiting in New York, NY?

Yes, NCT04997993 is currently recruiting participants at its New York, NY location. This pten-altered advanced solid tumors and her2 negative breast cancer clinical trial is actively enrolling qualified participants.

Q: How do I join the pten-altered advanced solid tumors and her2 negative breast cancer clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer Study in New York

Leflunomide in patients with PTEN-Altered advanced solid tumors or HER2 negative breast cancer. Phase 1A objectives are to determine the safety, tolerability, and the MTD of leflunomide in patients with PTEN-Altered advanced solid malignancies and HER2 negative breast cancer. Phase 1B objective is to assess preliminary evidence of clinical activity of leflunomide in these patient populations.

Sponsor: Deborah Doroshow

Who Can Participate

Inclusion Criteria

A) Advanced or metastatic solid tumor with lack of PTEN expression as determined by immunohistochemistry. Lack of PTEN expression is defined as the absence of staining in the tumor (\<5%), with strong positive staining of adjacent normal endometrium or stromal cells, using the monoclonal DAKO antibody 6H2.1.9 OR

B) Advanced or metastatic solid tumor with a deleterious somatic mutation in PTEN as determined by tissue or ctDNA testing in a CLIA laboratory and classified as deleterious in the ClinVar or COSMIC databases OR

C) Advanced or metastatic HER2 negative breast cancer. Patients must have received ≤ 3 prior cytotoxic chemotherapies for metastatic disease (immunotherapy does not count as a line of therapy), and up to 2 prior antibody drug conjugate regimens (eg, sacituzumab govitecan, trastuzumab deruxtecan). Patients with ER-positive breast cancer (ER\>10%) are eligible if they have had progressive disease after at least 1 prior CKD4/6 inhibitor. Patients must have received alpelisib or capivasertib if eligible for either therapy or must be intolerant to or have refused such therapy. °Patients with known PTEN altered breast cancer may participate regardless of lines of prior therapy if they meet criteria A or B.

Measurable disease only required for dose expansion in non-prostate ca patients

Patients with prostate cancer without measurable disease must have evaluable disease as assessed by serum PSA.

Patients must have progressed on, be refractory or intolerant of standard therapy for their cancer, if such a standard therapy exists.

Patients with treated brain metastases are eligible if follow-up brain imaging at least 4 weeks after CNS directed therapy shows no evidence of progression.

Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS directed therapy is not required and is unlikely to be required during the first cycle of therapy.

2 week or five half life treatment (whichever is shorter) washout from systemic therapy, surgery, or RT. Patients with prostate cancer receiving gonadotropin-releasing hormone agonists may continue their use while on study.

ECOG performance status 0-2.

Patients with HIV on effective anti-retroviral therapy with an undetectable viral load are eligible for this trial.

Adequate organ and marrow function as defined below:

Leukocytes ≥ 3,000/mcL

Absolute neutrophil count ≥ 1,000/mcL

Platelets ≥ 100,000/mcl

Total bilirubin ≤ 1.5 x ULN (or direct bilirubin, if patient has Gilbert's disease)

AST (SGOT)/ALT (SPGT) ≤ 3xULN

GFR (Cockroft-Gault) ≥ 40 mL/min/1.73m2

Negative serum or urine pregnancy test within 3 days prior to C1D1 of leflunomide therapy.

Women of child-bearing potential and men must agree to use adequate contraception before study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately and will immediately be taken off study therapy.

Additionally, all women of child bearing potential must begin an accelerated elimination protocol upon drug discontinuation for any reason, unless they agree to continue taking appropriate contraception for up to 2 years from study drug discontinuation.

Patients who do not take the accelerated elimination protocol will have to remain on contraception for two years.

Recommended methods of birth control are: The consistent use of an approved hormonal contraception such as an intrauterine device (IUD), birth control pills, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), sexual abstinence (no sexual intercourse) or sterilization. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

Has not undergone a hysterectomy or bilateral oophorectomy; or

Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 months).

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

Patients with primary CNS tumors are not eligible.

Patients who have had chemotherapy or radiotherapy within 4 weeks before entering the study or those who have not recovered from grade ≥ 2 adverse events due to agents administered more than 4 weeks earlier. Adverse events such as alopecia, hypothyroidism, and neuropathy are allowed. Other adverse events may be allowed by permission of the principal investigator.

Patients may not be receiving any other investigational agents.

A known history of acute or chronic Hepatitis B or C, due to the known potential hepatotoxicity of leflunomide.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to leflunomide or teriflunomide.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT04997993) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer Treatment Options in New York, NY

If you're searching for pten-altered advanced solid tumors and her2 negative breast cancer treatment options in New York, NY, this clinical trial (NCT04997993) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pten-altered advanced solid tumors and her2 negative breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pten-altered advanced solid tumors and her2 negative breast cancer clinical trials near you to find additional studies recruiting in your area.

PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer Clinical Trial in New York, NY

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