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First human trials for breast cancer vaccine finally underway as Cleveland woman becomes first recipient.


The first-ever recipient of a new breast cancer vaccine has been revealed to the public.

Ohio’s Jennifer Davis received the groundbreaking vaccine developed by Cleveland Clinic in October 2021.

She had previously battled triple-negative breast cancer and went into remission in 2018. She was chosen for the trial because there was a good chance that the cancer would return.

The shot she received is among hundreds of experimental cancer vaccines and drugs in early trials.

A cancer vaccine made by Moderna for patients recovering from advanced melanoma was given “breakthrough therapy” status by health chiefs last month, paving the way for accelerated approval.

Jennifer was diagnosed with triple-negative breast cancer during a typical work day in 2018

Ms. Davis receives the third dose of the breast cancer vaccine from research nurse coordinator Donna Lach

Ms. Davis receives the third dose of the breast cancer vaccine from research nurse coordinator Donna Lach

Ms. Davis, a nurse from Lisbon, Ohio, about 60 miles northwest of Pittsburgh, discovered a lump in her breast in February 2018.

Her first biopsy — a test done on tissue removed from a living person to check for disease — at a local hospital found no evidence of cancer.

But the nodule grew over the next few months, and Ms. Davis underwent another biopsy after an ultrasound showed abnormalities.

A week later, she was diagnosed with triple-negative breast cancer and underwent several rounds of chemotherapy and radiation, plus a double mastectomy — the removal of both breasts.

Triple-negative breast cancer makes up about 10-15 percent of all breast cancers.

It is called triple-negative because the cancer cells do not have estrogen or progesterone receptors and do not or hardly make the protein HER2.

In about 40 percent of people with stage one to three triple-negative breast cancer, the disease will return after treatment.

About 91 percent of all women with the disease are alive five years after diagnosis. However, if the cancer has spread, the five-year survival rate is 12 percent.

In general, triple-negative breast cancer has a poorer survival and cause-specific survival than non-triple-negative breast cancer.

During follow-up appointments, she learned about the breast cancer vaccine clinical trial at the Cleveland Clinic.

The shot works by targeting a lactation protein called α-lactalbumin, which is no longer present after breastfeeding in noncancerous tissues, but is present in most triple-negative breast cancers. The protein plays a key role in milk production.

If breast cancer occurs, the vaccine activates the immune system to attack the tumor and prevent it from getting bigger.

Ms. Davis is part of phase 1a of the study, which involves patients who have completed treatment for triple-negative early-stage breast cancer within the past three years.

These people must be tumor free but have a high risk of recurrence to be admitted.

She has received three doses of the vaccine, one every two weeks apart. Her last injection was in November 2021 and she has had no major side effects.

She underwent several rounds of chemotherapy and radiation, plus a double mastectomy

She underwent several rounds of chemotherapy and radiation, plus a double mastectomy

Jennifer with her close-knit family prior to her breast cancer treatment

Jennifer with her close-knit family prior to her breast cancer treatment

Dr. George Thomas Budd, breast oncologist and principal investigator of the breast cancer vaccine trial at the Cleveland Clinic, said: ‘Triple-negative breast cancer is the form of the disease for which we have the least effective treatments.

“In the long run, we hope that this could be a real preventative vaccine that would be administered to cancer-free individuals to prevent them from developing this very aggressive disease.”

Ms Davis said: ‘There’s no medication I take to make sure there’s no recurrence.

“With every ache and pain, your mind goes to the worst-case scenario. So I was very excited when I heard about the vaccine.’

In February 2023, Cleveland Clinic entered Phase 1b of the clinical trial.

This time it focuses on cancer-free individuals who are at high risk of developing breast cancer and who have undergone a prophylactic mastectomy to reduce their risk.

Ms. Davis, now 46, is celebrating her fifth year in remission.

One of the other cancer vaccines is Moderna’s for advanced melanoma.

It works by using mRNA technology that uses bits of genetic code from patients’ tumors to teach the body to fight the cancer.

The vaccine is given to people after surgery to prevent the tumor from coming back, and it’s tailor-made for each patient, meaning no two injections will be the same.

Merck and Moderna said they plan to start a phase three trial of the therapy this year, where it will be tested on potentially thousands of patients.

They will also “rapidly spread” to other cancers, including non-small cell lung cancer.

The federal government launched a major initiative last year to reduce cancer deaths called the Cancer Moonshot.

It follows increased investment in cancer screening, prevention and treatment in recent years.

Breast cancer is one of the most common cancers in the world, affecting more than two MILLION women each year

Breast cancer is one of the most common cancers in the world. Each year in the US there are about 264,000 new cases and the disease claims the lives of 42,000 women. But what causes it and how can it be treated?

What is breast cancer?

Breast cancer arises from a cancer cell that develops in the lining of a duct or lobule in one of the breasts.

When the breast cancer has spread to the surrounding breast tissue, it is called an ‘invasive’ breast cancer. Some people are diagnosed with “carcinoma in situ,” where no cancer cells have grown beyond the duct or lobule.

Most cases develop in women over the age of 50, but younger women are sometimes affected. Breast cancer can develop in men, although this is rare.

Staging means how big the cancer is and whether it has spread. Stage 1 is the earliest stage and stage 4 means the cancer has spread to another part of the body.

The cancer cells are graded from low, which means slow growth, to high, which means fast growth. High-grade cancers are more likely to come back after being treated first.

What Causes Breast Cancer?

A cancerous tumor starts with one abnormal cell. The exact reason why a cell becomes cancerous is unclear. Something is thought to damage or alter certain genes in the cell. This makes the cell abnormal and multiply ‘out of control’.

Although breast cancer can develop for no apparent reason, there are some risk factors that can increase the chance of developing breast cancer, such as heredity.

What Are the Symptoms of Breast Cancer?

The usual first symptom is a painless breast lump, although most breast lumps are not cancerous and are fluid-filled cysts, which are benign.

The first place where breast cancer usually spreads is the lymph nodes in the armpit. When this happens, you get a swelling or lump in an armpit.

How is breast cancer diagnosed?

  • Initial assessment: A doctor examines the breasts and armpits. They may perform tests such as a mammogram, a special X-ray of the breast tissue that can indicate the possibility of tumors.
  • Biopsy: A biopsy is when a small sample of tissue is removed from an area of ​​the body. The sample is then examined under a microscope to look for abnormal cells. The sample can confirm or rule out cancer.

If you are confirmed to have breast cancer, further tests may be needed to assess whether it has spread. For example, blood tests, an ultrasound of the liver or a chest x-ray.


How is breast cancer treated?

Treatment options that may be considered include surgery, chemotherapy, radiotherapy, and hormone treatment. Often a combination of two or more of these treatments is used.

  • Surgery: Breast-conserving surgery or removing the affected breast, depending on the size of the tumor.
  • Radiotherapy: A treatment that uses high-energy beams of radiation aimed at cancerous tissue. This kills cancer cells or stops cancer cells from multiplying. It is mainly used in addition to surgery.
  • Chemotherapy: A treatment for cancer using anticancer drugs that kill cancer cells or prevent them from multiplying.
  • Hormone treatments: Some types of breast cancer are affected by the “female” hormone estrogen, which can stimulate cancer cells to divide and multiply. Treatments that lower the level of these hormones or prevent them from working are commonly used in people with breast cancer.

How successful is the treatment?

The outlook is best in those who are diagnosed when the cancer is still small and has not spread. Surgical removal of a tumor at an early stage can then give a good chance of a cure.

Routine mammography offered to women between the ages of 50 and 70 means that more breast cancers are being diagnosed and treated at an early stage.

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