Is NCT07017673 recruiting in Torrance, CA?

Yes, NCT07017673 is currently recruiting participants at its Torrance, CA location. This breast cancer clinical trial is actively enrolling qualified participants.

How do I join the breast cancer clinical trial in Torrance?

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

Is participation in this Torrance 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.

Breast Cancer Clinical Trial in Torrance, CA

About This Breast Cancer Study in Torrance

This is a single arm phase II trial combination of ivonescimab and carbo-docetaxel every 3 weeks for 6 cycles in patients with early-stage triple negative breast cancer. The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant chemotherapy with carboplatin and docetaxel. Patients will receive ivonescimab 20 mg/kg IV on Day 1 of each cycle, and carboplatin AUC6 and docetaxel 75 mg/m2 on Day 1 of each cycle for 6 cycles. Cycles

Sponsor: Cedars-Sinai Medical Center

Who Can Participate

Inclusion Criteria

Age ≥ 18 years of age

High-risk early stage triple negative breast cancer (TNBC), defined by ER≤10%, PR≤10% and HER2 negative (by IHC or FISH), per ASCO/CAP guidelines

Clinically ≥T1cN0, or any T, N1-2

Plan to receive neoadjuvant chemotherapy and immune checkpoint inhibitor before surgery as standard-of-care treatment

Adequate organ function as defined in the following. Specimens must be collected within 14 days prior to the start of study treatment.

ANC ≥ 1,500/mm3

Platelets ≥ 100,000/mm3

Hemoglobin ≥ 9.0 g/dL.

Total serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 x ULN

AST \< 3 x ULN

ALT \< 3 x ULN

Creatinine clearance ≥ 30 mL/min

INR or PT, aPTT \< 1.5 x ULN

Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 14 days of start of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: If egg harvesting was completed prior to enrollment, the pregnancy test may be falsely positive and the PI will assess and determine eligibility for these cases.

Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies: \-- Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose.

Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria

Evidence of metastatic disease.

Is currently participating in or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.

History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to start of study treatment, including but not limited to:

Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.

Nasal bleeding/epistaxis (bloody nasal discharge is allowed)

Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable, in the opinion of the treating investigator, prior to start of study treatment is not allowed. The use of full-dose anticoagulants is permitted as long as the INR or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.

Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy

Women who are or are planning to become pregnant or breastfeed

Known allergy to any of the components within the study agents and/or their excipients

Medical history and concurrent diseases

Autoimmune diseases

Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years

History of (non-infectious) pneumonitis that required steroids or has current pneumonitis

Active infection requiring systemic therapy

Known history of Human Immunodeficiency Virus (HIV) infection

Known history of active Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority

Known history of active TB (Mycobacterium tuberculosis)

History of unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)

Prolongation of QTc interval \>480 msec

Prior allogeneic bone marrow transplantation or prior solid organ transplantation

History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to start of study treatment

History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to start of study treatment

Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before start of study treatment

History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to start of study treatment

Prohibited Treatments and/or Therapies

Other non-protocol specified anti-cancer therapy: systemic radiotherapy, immunotherapy, biologic, or hormonal therapy. tretinoin therapy, nitrosourea, mitomycin C, small molecule tyrosine kinase inhibitor therapy \--- Concomitant use of hormones for non-tumor-related conditions (e.g., insulin and hormone replacement therapy for diabetes mellitus) is acceptable

Any live vaccine within 30 days prior to the first dose of study drug and up to 120 days after the last dose. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed

Prior systemic therapy or radiation therapy with curative intent for the current breast cancer

A previous definitive ipsilateral breast surgery for the current breast cancer

Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137).

Immunosuppressive drugs, including, but not limited to, prednisone or equivalent, methotrexate, azathioprine, and TNF-α antagonists at doses exceeding 10 mg per day. The following exceptions are allowed:

The use of immunosuppressive drugs for the treatment of study drug-associated AEs or the use of immunosuppressive drugs in subjects with contrast allergy is acceptable.

The use of inhaled, topical, and intranasal glucocorticoids is permitted.

Corticosteroids are allowed as a prophylactic drug for hypersensitivity reactions (eg, before CT or MRI).

Corticosteroids are allowed as antiphylactic and therapeutic agents for chemotherapy-induced vomiting.

Short-term use of glucocorticoids for underlying or intercurrent conditions may be permitted after discussion with the PI.

Major surgery within 28 days prior to start of study treatment and within 4 weeks after first dose. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator.

Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.

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 Torrance?

Yes, this clinical trial (NCT07017673) has an active research site in Torrance, 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.

Breast Cancer Treatment Options in Torrance, CA

If you're searching for breast cancer treatment options in Torrance, CA, this clinical trial (NCT07017673) 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 Torrance research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced 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 breast cancer clinical trials near you to find additional studies recruiting in your area.

Breast Cancer Clinical Trial in Torrance, CA

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