New Posts New Posts RSS Feed - Breast Cancer Vaccine - Now Recruiting
  FAQ FAQ  Forum Search   Events   Register Register  Login Login

Breast Cancer Vaccine - Now Recruiting
 Post Reply Post Reply
Author
  Topic Search Topic Search  Topic Options Topic Options
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 13508 		Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Topic: Breast Cancer Vaccine - Now Recruiting
    Posted: Dec 22 2020 at 7:46am

FDA clears way for Cleveland Clinic’s groundbreaking breast cancer vaccine

But what if breast cancer could be wiped out altogether? 

That is the goal of a promising new breast cancer vaccine, 10 years in the making; invented and developed by Cleveland Clinic immunologist Dr. Vincent Tuohy.

“We know enough about the immune system now to try these things. We have the ability, but we’re on snail pace. We need to be on warp speed pace,” Tuohy said.

The clinic partnering with Anixa Biosciences, who has an exclusive worldwide license to the new technology.

This is how it would work. The technology immunizes against a protein that is expressed in the mammary glands of women, during the latter part of gestation and during lactation. That protein, often a precursor to cancer.

Dr. Amit Kumar, President & CEO of Anixa says, “It’s not absolutely clear why, but it starts being made again and we simply have to teach the immune system to destroy the cells making that protein. Because those are cancer cells.” 

Pre-clinical trials conducted on animals showed 100% of mice that were not vaccinated and got the placebo, developed breast cancer and died.

The vaccine’s initial focus is triple negative breast cancer, the most lethal … but is expected to eventually prevent other forms of cancer, including ovarian.

“So we envision a 21st century vaccine program here at the Cleveland Clinic that prevents diseases that we confront with age that we think are completely preventable,” Tuohy said. “We think breast cancer, ovarian cancer perhaps prostate cancer are all preventable diseases and that’s why we want to bring our vaccine program up to the 21st century.”

Now, with FDA clearance, human clinical trials for the breast cancer vaccine are expected to begin by Spring 2021.

https://fox8.com/news/fda-clears-way-for-cleveland-clinics-groundbreaking-breast-cancer-vaccine




Edited by 123Donna - Oct 26 2021 at 9:20am
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15
Back to Top
SagePatientAdvocates View Drop Down
Senior Advisor
Senior Advisor
Avatar

Joined: Apr 15 2009
Status: Offline
Points: 4748 		Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Dec 22 2020 at 6:11pm
Dear Donna, 

Thank you so much for posting this important news.

One thing I have noticed in the last 16 years of being a Patient Advocate are the number of Pregnancy Associated Breast Cancer (PABC) cases I have seen. I was told very early on in my work "PABC is very, very rare. You may never see it." That was not my experience in the beginning and I have seen an increase in the number of cases, over the years. To be honest, I have not kept track of the numbers but it definitely has been occurring, more often, anecdotally.

One of the first women I helped from this site was diagnosed while pregnant. I visited her while she was pregnant and she had mastectomies and started chemo while pregnant.  Both she and her little girl (now 10) are both healthy. Mom is cancer free and the child did not have cardio issues, that had been anticipated, from receiving the chemo.

PABC is defined as breast cancer that is found while the woman is pregnant or within the first year after given birth. I have helped several dozen women who discovered their masses (which turned out to be malignant) while breast feeding.

How wonderful it would be if the protein, behind this cancer, as suggested by Cleveland Clinic can be stopped from stimulating cancer. 

Thanks again, Donna.

warmly,

Steve
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
Back to Top
Vivian View Drop Down
Groupie
Groupie


Joined: Dec 28 2019
Status: Offline
Points: 51 		Post Options Post Options   Thanks (0) Thanks(0)   Quote Vivian Quote  Post ReplyReply Direct Link To This Post Posted: Dec 22 2020 at 11:44pm
This is such exciting news! Thank you for sharing, Donna! I dream for the day that breast cancer is no more a threat to us.  
Dx 12-27-2019 TN,Stg 1, Grade 3 Ultrasound 1.5cm/MRI 1.8cm, node-,BRAC-.
DD AC x 4, ultrasound cCR;
DD T x 4
Lumpectomy:5-28-2020; 0/2 nodes. pCR.
Radiation: 20x
Back to Top
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 13508 		Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 08 2021 at 12:30pm
Key Takeaways
  • The FDA has approved a triple-negative breast cancer vaccine for use in human clinical trials. 
  • The vaccine was developed by researchers at the Cleveland Clinic in Ohio and works by training the immune system to kill cells that express the protein alpha-lactalbumin. 
  • The technology used to develop the vaccine could be applicable to cancers beyond breast cancer as well.
" . . . The vaccine, Tuohy tells Verywell, essentially works by nipping tumor development in the bud. By imbuing immune cells with the ability to recognize, attack, and kill cancer cells, it prevents them from ever reaching a size at which they could inflict lethal damage on the body. Triple-negative breast cancer cells are distinctive because they express the protein alpha-lactalbumin, a major component of breast milk, even when their host is not pregnant or breastfeeding.

“Most triple-negative breast cancers express alpha-lactalbumin," Tuohy says. "It is a mistake that the tumors make because they have no default inhibition mechanisms through progesterone and estrogen signaling that would ordinarily prevent the expression of this protein." He describes the vaccine mechanism as “simply taking advantage of this mistake.”

What This Means For You

It's not currently known when this vaccine may be available to the general public. If it proves to be effective and approved for use several years down the line, you will not be eligible to receive the vaccine if you are breastfeeding or plan to breastfeed in the future. What Happens Next?

The FDA’s approval clears the way for the Cleveland Clinic to start Phase I clinical trials of the vaccine. Set to be helmed by George Thomas Budd, MD, staff physician at the Cleveland Clinic’s Taussig Cancer Center, the trials will also include men, who constitute about 1% of all breast cancer patients, Tuohy reports.3

Ideally, the trials will help doctors determine whether the vaccine can be safely administered to human beings by providing insight into dose size, dose number, and immunity duration. But it is hard to know exactly when the results might arrive. 

“My team takes [it] one day at a time," Tuohy says. "We hope to start the trials by the end of [the second quarter of] 2021, but we have been wrong so many times with such anticipated timelines. We hope to finish Phase I trials within two years after starting them." He adds that he has "no idea” when the vaccine might become widely available. 

The preliminary results of several animal studies conducted by the clinic have been promising. In one study of female mice, every single one of those that did not receive the vaccine subsequently developed breast cancer and died.1         

The trials will be funded by the U.S. Department of Defense and conducted in people who do not intend to breastfeed, Tuohy says.3 Because the vaccine conditions the immune system to wipe out all alpha-lactalbumin-expressing cells, it would have adverse effects on human milk production. . . .

. . .

The Future of Cancer Vaccine Development 

Cancer vaccines can be divided into two camps: those designed to prevent cancer, like Tuohy’s, and those designed to treat it. The only direct cancer treatment vaccines currently available are sipuleucel-T/Provenge (for the treatment of advanced prostate cancer) and talimogene laherparepvec/T-VEC (for the treatment of advanced melanoma, an aggressive form of skin cancer).4

Many breast cancer treatment vaccines are in development, including peptide-based vaccines, whole-cell vaccines, gene-based vaccines, and dendritic cell-based vaccines, but none have yet advanced past Phase II clinical trials.5

The candidates hail from organizations all around the country, including the Mayo Clinic in Jacksonville, Florida, the University of Washington in Seattle, and the University of Texas M.D. Cancer Center in Houston, according to Pravin Kaumaya, PhD, professor of translational therapeutics at the Ohio State University Comprehensive Cancer Center. . . ."

https://www.verywellhealth.com/breast-cancer-vaccine-greenlit-clinical-trials-5094403




Edited by 123Donna - Jan 08 2021 at 12:30pm
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15
Back to Top
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 13508 		Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 30 2021 at 7:31pm

FDA clears way for Cleveland Clinic’s groundbreaking breast cancer vaccine

That is the goal of a promising new breast cancer vaccine, 10 years in the making; invented and developed by Cleveland Clinic immunologist Dr. Vincent Tuohy.

“We know enough about the immune system now to try these things. We have the ability, but we’re on snail pace. We need to be on warp speed pace,” Tuohy said.

The clinic partnering with Anixa Biosciences, who has an exclusive worldwide license to the new technology.

This is how it would work. The technology immunizes against a protein that is expressed in the mammary glands of women, during the latter part of gestation and during lactation. That protein, often a precursor to cancer.

Dr. Amit Kumar, President & CEO of Anixa says, “It’s not absolutely clear why, but it starts being made again and we simply have to teach the immune system to destroy the cells making that protein. Because those are cancer cells.” 

Pre-clinical trials conducted on animals showed 100% of mice that were not vaccinated and got the placebo, developed breast cancer and died.

The vaccine’s initial focus is triple negative breast cancer, the most lethal … but is expected to eventually prevent other forms of cancer, including ovarian.

“So we envision a 21st century vaccine program here at the Cleveland Clinic that prevents diseases that we confront with age that we think are completely preventable,” Tuohy said. “We think breast cancer, ovarian cancer perhaps prostate cancer are all preventable diseases and that’s why we want to bring our vaccine program up to the 21st century.”

Now, with FDA clearance, human clinical trials for the breast cancer vaccine are expected to begin by Spring 2021.

https://fox8.com/news/fda-clears-way-for-cleveland-clinics-groundbreaking-breast-cancer-vaccine
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15
Back to Top
SagePatientAdvocates View Drop Down
Senior Advisor
Senior Advisor
Avatar

Joined: Apr 15 2009
Status: Offline
Points: 4748 		Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Jan 31 2021 at 10:03am
Dear Donna,

Many thanks for the update.

Praying this will work.

warmly,

Steve
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
Back to Top
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 13508 		Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 31 2021 at 11:07am
Hi Steve,

Me too!  It's been a long 10 years in development just to reach human trials this spring.

Donna
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15
Back to Top
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 13508 		Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 31 2021 at 11:28am

Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer

Brief Summary:
The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer

Condition or disease Intervention/treatment Phase 
Stage IIA Triple Negative Breast CancerTriple Negative Breast CancerBiological: α-lactalbumin vaccineBiological: ZymosanEarly Phase 1

Detailed Description:
This aLA breast cancer vaccine is an investigational (experimental) drug that the study team believes will work by stimulating the immune system to fight the participant's cancer, in a way similar to the way the immune system fights off an infection after a vaccination for that infection. α-lactalbumin Vaccine is experimental because it is not approved by the Food and Drug Administration (FDA).
Study Design
Go to  < ="tr-dropbtn" style="-sizing: border-; margin: 0px; overflow: ; text-trans: none; appearance: ; cursor: pointer; font-weight: bold; font-size: 14px;">sections
Study Type  :Interventional  (Clinical Trial)
Estimated Enrollment  :30 participants
Allocation:N/A
Intervention Model:Single Group Assignment
Masking:None (Open Label)
Primary Purpose:Treatment
Official Title:Phase I Trial of Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Patients With Non-Metastatic Triple-Negative Breast Cancer at High Risk of Recurrence
Estimated Study Start Date  :March 2021
Estimated Primary Completion Date  :October 2021
Estimated Study Completion Date  :December 2021


Inclusion Criteria:

  • Histologically proven invasive breast cancer.

  • Primary tumor must be ER-negative (ER in <1% of cells), PR-negative (PR in <1% of cells), and HER2-negative (0-1+ by IHC or FISH ratio<2.0 with signal number <6/cell). 4.1.3 Patients must be high risk, defined as either:

    • Pathologic stage IIA, IIB, IIIA, IIIB, or IIIC by AJCC 8, or

    • Residual invasive cancer in breast or regional nodes following preoperative chemotherapy.

      • 1 months since last active therapy (chemotherapy, radiation therapy, or surgery) and <36 months since the initiation of treatment for the current cancer, based on the period of highest risk for patients with Stages I-III triple-negative breast cancer
  • Treatment prior to enrollment must be consistent with contemporary NCCN guidelines, found at: https://www.nccn.org/
  • ECOG Performance Status 0-1

  • Adequate major organ function, defined as:

    • WBC > 3,000/mcl,
    • hemoglobin > 10.0 gm/dL,
    • platelets > 100,000/mcL,
    • total bilirubin within normal limits,
    • ALT/AST <3 x upper limits of normal (ULN),
    • serum creatinine < 1.5 x ULN
  • Serum prolactin level must be < upper limits of normal (ULN);
  • Participants must have the ability to understand and the willingness to sign and provide a written informed consent document;
  • Participants must have archival tissue available for potential correlative studies (e.g., assays for α-lactalbumin expression or tumor infiltrating lymphocytes), but tumors will not be required to exhibit overexpression of α-lactalbumin for enrollment.
  • Participants agrees not to use alternative therapies from the time of informed consent through 30 days following the last vaccine injection
Locations
United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44915
Contact: George T Budd, MD    866-223-8100    TaussigResearch@ccf.org   
Principal Investigator: George T Budd, MD   

https://clinicaltrials.gov/ct2/show/NCT04674306
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15
Back to Top
Lorene View Drop Down
Senior Member
Senior Member


Joined: Jul 10 2010
Location: Alabama
Status: Offline
Points: 211 		Post Options Post Options   Thanks (0) Thanks(0)   Quote Lorene Quote  Post ReplyReply Direct Link To This Post Posted: Feb 02 2021 at 11:23am
Donna,
 What wonderful news on the possibility of a breast cancer vaccine!  Thank you for keeping up with these things And sharing it!

Lorene
dx10/01@age59,IDC TNBC, St.IIB,Gr3,2.5cm,3+nodes, epirubicin,5FU,cytoxan,33Rads,No recurrence, 2018
Back to Top
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 13508 		Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: May 11 2021 at 8:19am
Update: Trial has not started recruiting.

ClinicalTrials.gov Identifier: NCT04674306

Recruitment Status : Not yet recruiting
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15
Back to Top
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 13508 		Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Oct 26 2021 at 9:19am
IMPORTANT UPDATE:  NOW RECRUITING

Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer

ClinicalTrials.gov Identifier: NCT04674306
Recruitment Status  : Recruiting
First Posted  : December 19, 2020
Last Update Posted  : October 12, 2021

Brief Summary:
The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer

Condition or disease Intervention/treatment Phase 
Pathologic Stage IIA-IIIC Triple-Negative Breast CancerTNBC - Triple-Negative Breast CancerResidual DiseaseBiological: α-lactalbumin vaccineBiological: ZymosanEarly Phase 1

Detailed Description:

This is an open-label, phase I dose-escalation trial in which successive cohorts of participants with high-risk triple-negative breast cancer will be treated with successively higher doses of α-lactalbumin and zymosan

This aLA breast cancer vaccine is an investigational (experimental) drug that the study team believes will work by stimulating the immune system to fight the participant's cancer, in a way similar to the way the immune system fights off an infection after a vaccination for that infection. α-lactalbumin Vaccine is experimental because it is not approved by the Food and Drug Administration (FDA).

A traditional "3+3" Phase I trial design will be employed to determined the Maximum Tolerated Dose (MTD). After identification of the MTD, if at least 1 participant has an immunologic response (correlative measurement), successively lower dose levels will be expanded to a total of 6 participants and immunologic response assessed. Enrollment will stop if a dose level is reached for which no responses are observed. Dose-Limiting toxicities (DLTs) in 2 or more of 6 participants, the next lower dose will be considered the new MTD.

Objectives are to determine MTD, DLT incidence, and Lowest Immunologic Dose (LID).

Toxicity will be assessed every 2 weeks until day 56 and at day 84 or at off-study. Participants will be offered participation in long-term follow-up involving contact or in-person follow-up for late toxicity and survival every 3 months for 2 years, every 6 months for an additional 3 years, and then annually for 10 years.

Study Design
Go to  < ="tr-dropbtn" style="-sizing: border-; margin: 0px; overflow: ; text-trans: none; appearance: ; cursor: pointer; font-weight: bold; font-size: 14px;">sections
Study Type  :Interventional  (Clinical Trial)
Estimated Enrollment  :24 participants
Allocation:N/A
Intervention Model:Single Group Assignment
Masking:None (Open Label)
Primary Purpose:Treatment
Official Title:Phase I Trial of Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Patients With Non-Metastatic Triple-Negative Breast Cancer at High Risk of Recurrence
Actual Study Start Date  :October 1, 2021
Estimated Primary Completion Date  :May 2022
Estimated Study Completion Date  :September 2022
Contacts
Contact: George T Budd, MD1-866-223-8100TaussigResearch@ccf.org

Locations
United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer CenterRecruiting
Cleveland, Ohio, United States, 44915
Contact: George T Budd, MD    866-223-8100    TaussigResearch@ccf.org   
Principal Investigator: George T Budd, MD         
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15
Back to Top
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 13508 		Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Nov 08 2021 at 6:59pm
Trials begin for first vaccine candidate to prevent triple-negative breast cancer

  • Human trials are underway for a vaccine against the most aggressive and deadly form of breast cancer.
  • The phase 1 trial will include early stage triple-negative breast cancer survivors who are at high risk for recurrence.
  • The vaccine targets a protein called α-lactalbumin and alerts the immune system to halt tumor growth.
  • Although it is too early to call this finding a breakthrough, if the trial progresses, it could possibly inspire similar shots for other cancers, as well.

Following clearance from the Food and Drug Administration (FDA) for the testing of the experimental new drug, the Cleveland Clinic and partner Anixa Biosciences, Inc. launched the study in early October to determine the correct dosage for the vaccine.

Initially, the trial will include 18–24 participants, all of whom have received treatment for early stage TNBC in the past 3 years. Although doctors have declared each person tumor-free, they are at high risk for recurrence.

The scientists running the trial will administer the vaccine as three shots with 2 weeks between each dose. They will closely monitor the participants for side effects and immune response.

The trial will include a larger number of participants, who will be in good health, if the dosage proves to be safe and effective.

To read the entire article:
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15
Back to Top
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 13508 		Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 15 2023 at 11:22am
Cleveland Clinic researchers launch the next step in triple-negative breast cancer vaccine study

Cleveland Clinic researchers have launched the next step in their novel study of a vaccine aimed at preventing triple-negative breast cancer, the most aggressive and lethal form of the disease.

Funded by the U.S. Department of Defense, the new phase 1b study will enroll cancer-free individuals at high risk for developing breast cancer who have decided to voluntarily undergo prophylactic mastectomy to lower their risk.

Individuals in that category typically carry genetic mutations that put them at risk of developing triple-negative breast cancer or have high familial risk for any breast cancer. The study, conducted at Cleveland Clinic's main campus, will evaluate safety and monitor immune response.

The new study will include approximately 6-12 patients and is anticipated to be complete by the end of 2023. Study participants will receive three vaccinations given two weeks apart and will be closely monitored for side effects and immune response.

The phase 1b clinical trial, conducted in partnership with Anixa Biosciences, Inc., follows the ongoing phase 1a study, which opened in 2021 and is expected to be complete in the 4th quarter of 2023. The phase 1a trial includes patients who completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.

Triple-negative breast cancer is the form of the disease for which we have the least effective treatments. Long term, we are hoping that this can be a true preventive vaccine that would be administered to cancer-free individuals to prevent them from developing this highly aggressive disease.".

G. Thomas Budd, M.D., of Cleveland Clinic's Taussig Cancer Institute and principal investigator of the study

According to Dr. Budd, there is a great need for improved treatments for triple-negative breast cancer, which does not have biological characteristics that typically respond to hormonal or targeted therapies. Despite representing only about 12% to 15% of all breast cancers, triple-negative breast cancer accounts for a disproportionately higher percentage of breast cancer deaths. It is twice as likely to occur in Black women, and approximately 70 to 80% of the breast tumors that occur in women with mutations in the BRCA1 gene are triple-negative breast cancer.

The vaccine is based on pre-clinical research led by the late Vincent Tuohy, Ph.D., who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic's Lerner Research Institute. Dr. Tuohy was an outstanding and passionate scientist and his decades of groundbreaking research led to the development of this investigational vaccine.

The vaccine targets a lactation protein, α-lactalbumin, which is no longer found after lactation in normal, aging tissues but is present in the majority of triple-negative breast cancers. If breast cancer develops, the vaccine is designed to prompt the immune system to attack the tumor and keep it from growing.

The study is based on Dr. Tuohy's research that showed that activating the immune system against α-lactalbumin was safe and effective in preventing breast tumors in mice. The research, originally published in Nature Medicine, was funded in part by philanthropic gifts from more than 20,000 people over the last 12 years.

"It was Dr. Tuohy's hope that this vaccine would demonstrate the potential of immunization as a new way to control breast cancer, and that a similar approach could someday be applied to other types of malignancy," added Dr. Budd.

https://www.news-medical.net/news/20230208/Cleveland-Clinic-researchers-launch-the-next-step-in-triple-negative-breast-cancer-vaccine-study.aspx
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15
Back to Top
cookie54 View Drop Down
Groupie
Groupie
Avatar

Joined: Oct 24 2020
Location: New Jersey
Status: Offline
Points: 67 		Post Options Post Options   Thanks (0) Thanks(0)   Quote cookie54 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2023 at 8:07am
Donna, Thanks for sharing this great news!
8/16,IDC,StageIA,Gr3,0/1 nodes ER-PR-HER2-
9/16 BMX,AC
6/20,StageIIIC,Gr3,ER-/PR-HER2-
6/20 Carbo/Gem/pembro
10/20 ALND 5/8 nodes,Rad x25
11/20 thyroid ca
Xeloda2/21
Stage IV 6/22 lung mets
Back to Top
 Post Reply Post Reply
  Share Topic   

Forum Jump Forum Permissions View Drop Down

Forum Software by Web Wiz Forums® version 12.01
Copyright ©2001-2018 Web Wiz Ltd.