Duarte, CANCT04020575Now EnrollingIRB Ready

Metastatic Breast Cancer Clinical Trial in Duarte, CA

Access cutting-edge metastatic breast cancer treatment through this clinical trial at a research site in Duarte. Study-provided care at no cost to qualified participants.

Sponsored by Minerva Biotechnologies Corporation

Quick Self-Assessment

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Expert Care in Duarte

Access metastatic breast cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related metastatic breast cancer treatment provided free

Apply for This Duarte Location

Check if you qualify for this metastatic breast cancer clinical trial in Duarte, CA

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Why Participate?

  • No-Cost Study Care

  • Local to Duarte

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Duarte site if eligible
  4. 4Begin participation

About This Metastatic Breast Cancer Study in Duarte

Phase I/II study of adoptive immunotherapy for advanced MUC1\* positive breast cancer with autologous T cells engineered to express either a chimeric antigen receptor, huMNC2-CAR44 or huMNC2-CAR22, which are specific for a cleaved form of MUC1 (MUC1\*).

Sponsor: Minerva Biotechnologies Corporation

Who Can Participate

Inclusion Criteria

Confirmation of diagnosis of breast cancer by pathology review of initial or subsequent biopsy or other pathologic material at the City of Hope Pathology department. ER, PR, and HER2 status known and documented per ASCO/CAP guidelines.
For dose expansion cohorts, tumors with ER and/or PR ≥1% will be considered hormone receptor positive. Tumors with ER and PR \<1% will be considered hormone receptor negative. HER2 status will be determined by IHC or FISH per ASCO/CAP guidelines. Patients will be allocated to expansion cohorts according to guidelines in table below.
Dose expansion cohorts Expansion Cohort Hormone Receptor status HER2 status Luminal ER and/or PR \>/=1% positive Negative by IHC or FISH HER2 positive Any ER or PR status Positive by IHC or FISH Triple Negative ER and PR \<1% Negative by IHC or FISH
Patients must have received standard metastatic systemic therapy per NCCN guidelines or institutional practice which are known to confer benefit. No maximum on number of prior systemic treatment regimens.
Patients with hormone receptor positive disease must have received at least 3 prior endocrine therapies and at least 2 prior lines of chemotherapy in the metastatic setting.
Patients with HER2 positive breast cancer must have received at least 3 prior HER2- directed therapies (trastuzumab, pertuzumab, TDM-1 or others) in the metastatic setting.
Patients with triple negative disease must have received at least 2 prior lines of chemotherapy in the metastatic setting.
membrane expression ≥30% by immunohistochemistry on a tumor specimen obtained at screening or previous tumor specimen that is less than 6-months old (see Appendix I for examples of MUC1\
expression patterns).
Patients must be 18 years of age or older, of any gender, race or ethnicity.
Patients must be capable of understanding and providing a written informed consent.
Patients must have a Karnofsky performance status of ≥60%.
Patients must have measurable disease by at least one of the criteria below:
Extra skeletal disease that can be accurately measured by CT or MRI per RECIST 1.1,
Skeletal or bone-only metastases measurable by FDG PET imaging.
Negative serum pregnancy test within 14 days of planned leukapheresis and within 28 days of lymphodepleting chemotherapy for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year.
Fertile male and female patients must be willing to use an effective contraceptive method before, during, and for at least 4 months after the huMNC2-CAR T cell infusion.

Exclusion Criteria

Patients requiring ongoing daily corticosteroid therapy at a dose of \>15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable.
Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the PI.
Major organ dysfunction defined as:
Serum creatinine \> 2 mg/dL
Bilirubin ≥ 1.5 mg/dL with the following exception: Patients with known Gilbert disease, serum bilirubin \> 3 mg/dL
AST or ALT ≥ 2.5 x upper institutional limit of normal with the following exception: Patients with known hepatic metastases, AST or ALT \> 3x upper institutional limit of normal
Patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing. Those with an FEV1 of \< 50 % of predicted or DLCO (corrected) \< 40% will be excluded.
Significant cardiovascular abnormalities as defined by any one of the following: i. NYHA class III or IV congestive heart failure, ii. clinically significant hypotension, iii. uncontrolled symptomatic coronary artery disease, or iv. a documented ejection fraction of \<45%. Any patient with an EF of 45-49% must receive clearance by a cardiologist to be eligible for the trial.
ANC \<1000/mm\^3.
Hemoglobin \<9 mg/dl (transfusion permitted to achieve this).
Platelet count \<75,000/mm\^3.
Treatment with investigational agent(s) within 30 days of planned lymphodepletion.
HIV seropositive.
Uncontrolled active infection.
Anticipated survival of \<3 months.
Breast-feeding women.
Patients who have a contraindication to cyclophosphamide chemotherapy.
Known second malignancy that is progressing or requires active treatment.
Untreated CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate with documented stable disease as defined by no evidence of progression by imaging or symptoms for at least 4 weeks prior to enrollment.
Have psychiatric illness, social situation, or other medical condition that would preclude informed consent to limit compliance with study requirements, as determined by the investigator.

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 Duarte?

Yes, this clinical trial (NCT04020575) has an active research site in Duarte, CA 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.

Metastatic Breast Cancer Treatment Options in Duarte, CA

If you're searching for metastatic breast cancer treatment options in Duarte, CA, this clinical trial (NCT04020575) 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 Duarte research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic 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 metastatic breast cancer clinical trials near you to find additional studies recruiting in your area.

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