Panitumumab and Pembrolizumab in Combination With Neoadjuvant Chemotherapy for the Treatment of S… (NCT05177796) | Clinical Trial Compass
WithdrawnPhase 2
Panitumumab and Pembrolizumab in Combination With Neoadjuvant Chemotherapy for the Treatment of Stage III-IV Triple Negative Breast Cancer
Stopped: 0 participants recruited
United States0Started 2022-03-11
Plain-language summary
This phase II trial tests whether panitumumab and pembrolizumab in combination with standard of care chemotherapy before surgery (neoadjuvant) works to shrink tumors in patients with stage III-IV triple negative breast cancer. Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab and pembrolizumab in combination with neoadjuvant chemotherapy may kill more tumor cells in patients with triple negative breast cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to understand and the willingness to provide written informed consent for the trial
. Female or male and \>/= 18 years of age
. Histological confirmation of invasive breast cancer. All histologic subtypes are eligible.
. Clinical diagnosis of IBC and amenable to breast surgery Cohort 1 (safety run-in), stage III or de novo stage IV Cohort 2, stage III or de novo stage IV
. Known ER, PR, and HER2 status defined as triple negative breast cancer (TNBC). TNBC is defined as ER and PR ≤ 10% by immunohistochemistry, and HER2 negative (defined as IHC 0, 1+, or 2+ and FISH negative. The positivity of FISH is determined as per ASCO/CAP guideline.(46)
. ECOG performance status of 0-1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The ( pCR ) rate pathological complete response, defined as the absence of invasive carcinoma in the breast and the lymph nodes.
Timeframe: through study completion, an average of 1 year
. Adequate organ function as determined by the following laboratory values:
. Subjects of childbearing potential should be willing to use effective methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of study drug. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>1 year. Effective methods of birth control include 1) Use of hormonal birth control methods: pills, shots/injections, implants (placed under the skin by a health care provider), or patches (placed on the skin); 2) Intrauterine devices (IUDs); 3) Using 2 barrier methods (each partner must use 1 barrier method) with a spermicide. Males must use the male condom (latex or other synthetic material) with spermicide. Females must choose either a Diaphragm with spermicide, or Cervical cap with spermicide, or a sponge (spermicide is already in the contraceptive sponge).
Exclusion criteria
. Any other previous or concurrent antitumor therapies for the current cancer diagnosis event.
. Known diagnosis of immunodeficiency, which defined as on chronic systemic steroid therapy or any other forms of immunosuppressive therapy in excess of the equivalent of prednisolone 10 mg once daily.
. History of malignancy (other than breast cancer) within 5 years, except basal cell carcinoma or squamous cell carcinoma of the skin, melanoma in-situ or in situ cervical cancer that has undergone potentially curative therapy.
. Known active central nervous system metastases and/or carcinomatous meningitis.
. Known significant cardiovascular disease, such as a history of myocardial infarction, acute coronary syndrome, Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV, or history of CHF NYHA Class III or IV.
. Ejection fraction \< 50% by ECHO or MUGA.
. Known active or uncontrolled autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids chronic corticosteroid use or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.