The first ever recipient of a new breast cancer vaccine has been revealed to the public.
Jennifer Davis, of Ohio, received the breakthrough 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 as there was a high chance the cancer would return.
The shot she received is among hundreds of experimental cancer vaccines and medicines in early trials.
One 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 a fast-tracked approval.
Jennifer was told she had triple-negative breast cancer during a regular day at work in 2018
Ms Davis receives the third dose of the breast cancer vaccine from research nurse coordinator Donna Lach
Ms Davis, a nurse from Lisbon, Ohio, around 60 miles northwest of Pittsburgh, found a lump in her breast in February 2018.
Her first biopsy — a test done on tissue removed from a living person to check for a disease — at a local hospital found no evidence of cancer.
But the lump grew over the next few months and Ms Davis had 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 masectomy — 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 also do not make any or much of the protein named HER2.
Roughly 40 percent of people with stage one to three triple-negative breast cancer will have the disease recur after treatment.
About 91 percent of all women with the disease are still alive five years post-diagnosis. However if the cancer has spread, the five-year survival rate is 12 percent.
Overall, triple-negative breast cancer has worse 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 Cleveland Clinic.
The shot works by targeting a lactation protein called α-lactalbumin, which is no longer present after lactation in non-cancerous tissues but is present in the majority of triple-negative breast cancers. The protein plays a key role in milk production.
If breast cancer occurs, the vaccine triggers the immune system to attack the tumor and stop it from getting any bigger.
Ms Davis is part of phase 1a of the study, which involves patients who completed treatment for early-stage triple-negative breast cancer in the past three years.
These people must be tumor-free but at high risk of recurrence to be included.
She has been given three doses of the vaccine, each two weeks apart. Her last shot was in November 2021, and she has not suffered any major side effects.
She underwent several rounds of chemotherapy and radiation, plus a double masectomy
Jennifer with her close-knit family prior to her breast cancer treatment
Dr George Thomas Budd, breast medical oncologist and principal investigator for the breast cancer vaccine trial at Cleveland Clinic, said: ‘Triple-negative breast cancer is the form of the disease for which we have the least effective treatments.
‘Long term, we are hoping this can be a true preventive vaccine that would be administered to cancer-free individuals to prevent them from developing this highly aggressive disease.’
Ms Davis said: ‘There is no medication I take to make sure there’s not a 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 started on phase 1b of the clinical trial.
This time, it focuses on cancer-free individuals at high-risk for developing breast cancer and who have undergone a prophylatctic mastectomy to reduce their risk.
Ms Davis, now 46, is celebrating her fifth year in remission.
Among the other cancer vaccines is Moderna’s for advanced melanoma.
It works by harnessing mRNA technology that uses pieces of genetic code from patients’ tumors to teach the body to fight off the cancer.
The vaccine is given to people post-surgery to prevent the tumor from returning, and it is tailored to each patient, meaning no two shots will be the same.
Merck and Moderna said they plan to initiate a phase three study into the therapy this year, where it will be tested on potentially thousands of patients.
They will also ‘rapidly expand’ to looking at other cancers, including non-small cell lung cancer.
The federal government has a big initiative to reduce cancer deaths launched last year, called the Cancer Moonshot.
It follows more investment into cancer screening, prevention and treatment in recent years.
Breast cancer is one of the most common cancers in the world and affects more than two MILLION women a year
Breast cancer is one of the most common cancers in the world. Each year in the US there are around 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 develops from a cancerous cell which develops in the lining of a duct or lobule in one of the breasts.
When the breast cancer has spread into 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, though 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 cancerous cells are graded from low, which means a slow growth, to high, which is fast-growing. High-grade cancers are more likely to come back after they have first been treated.
What causes breast cancer?
A cancerous tumour starts from one abnormal cell. The exact reason why a cell becomes cancerous is unclear. It is thought that something damages or alters 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 genetics.
What are the symptoms of breast cancer?
The usual first symptom is a painless lump in the breast, although most breast lumps are not cancerous and are fluid filled cysts, which are benign.
The first place that breast cancer usually spreads to is the lymph nodes in the armpit. If this occurs you will develop a swelling or lump in an armpit.
How is breast cancer diagnosed?
- Initial assessment: A doctor examines the breasts and armpits. They may do tests such as a mammography, a special x-ray of the breast tissue which can indicate the possibility of tumours.
- Biopsy: A biopsy is when a small sample of tissue is removed from a part 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 if it has spread. For example, blood tests, an ultrasound scan of the liver or a chest X-ray.
How is breast cancer treated?
Treatment options which may be considered include surgery, chemotherapy, radiotherapy and hormone treatment. Often a combination of two or more of these treatments are used.
- Surgery: Breast-conserving surgery or the removal of the affected breast depending on the size of the tumour.
- Radiotherapy: A treatment which uses high energy beams of radiation focused on cancerous tissue. This kills cancer cells, or stops cancer cells from multiplying. It is mainly used in addition to surgery.
- Chemotherapy: A treatment of cancer by using anti-cancer drugs which kill cancer cells, or stop them from multiplying.
- Hormone treatments: Some types of breast cancer are affected by the ‘female’ hormone oestrogen, which can stimulate the cancer cells to divide and multiply. Treatments which reduce the level of these hormones, or prevent them from working, are commonly used in people with breast cancer.
How successful is treatment?
The outlook is best in those who are diagnosed when the cancer is still small, and has not spread. Surgical removal of a tumour in an early stage may then give a good chance of cure.
The routine mammography offered to women between the ages of 50 and 70 means more breast cancers are being diagnosed and treated at an early stage.
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