Study: Immunotherapy may lead to long-term remission of metastatic breast cancer
Contents
At a glance | Media coverage |
Findings | In-depth |
Clinical trials | Limitation |
Questions for your doctor | Resources |
STUDY AT A GLANCE
This study is about:
Adoptive cell therapy (ACT), a new treatment for breast cancer that resulted in complete tumor regression in 1 patient.
Why is this study important?
breast cancer is breast cancer that has spread beyond the breast and to other places in the body.
breast cancer can be difficult to treat when cancer cells have spread to many parts of the body. treatment like the one in this study boost the patient’s own immune system to better fight cancer.
This study is important because it is an example of a new, personalized treatment approach that resulted in complete shrinking of one woman's breast cancer—an unusual occurrence.
Study findings:
This research is a case study of one woman with breast cancer that responsed very well to this treatment.
Before treatment, the 49-year old patient had advanced ER-positive, HER2-negatve breast cancer, with tumors in her breast, chest wall and . Several standard treatments, including different chemotherapies, were unsuccessful in treating her cancer.
In an ongoing clinical trial, the woman was given an experimental treatment called "adoptive cell therapy" (ACT). Researchers used the patient's own immune cells—specifically ones that could recognize and attack her tumor cells. These immune cells (called tumor-infiltrating lymphocytes, or TILs) were grown in the lab; and then injected back into the patient.
The result was surprisingly effective. At 22 months after treatment, none of the tumors that were present before treatment were detected.
Update
Read an update from the patient Judy Perkins, whose 4 cancer is still in remission as of March 2019 after treatment with T-cell therapy.
What does this mean for me?
If you have breast cancer, you will likely first receive a standard of care treatment. The study in this review is very early research. The safety and effectiveness of this treatment for a larger number of patients is not yet known. While this woman responded well and is now living with no evidence of disease (NED), researchers do not know whether her response will be typical, if it will vary between patients, if it was a fluke, or if unintended side effects might occur. It may be some time before we understand who will respond best to this treatment.
This woman was part of an ongoing clinical trial to test this treatment. This trial is enrolling participants who have breast, ovarian, endometrial or other types of cancer. Patients in this study must have a tumor that can be safely removed. Patients must have tumors that are resistant to standard treatment. If this fits your situation, you may want to consider participating in this trial or in a related study. More information on eligibility for this trial can be found here, or for other trials for breast cancer at the following link. You can search for open trials with our clinical trial research tool or through ClinicalTrials.gov.
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References
Zacharakis N, Chinnasamy H, Black M, et al. "Immune recognition of leading to complete durable regression in breast cancer." Nature Medicine. 2018;24:724-730.
Mariotto AB, Etzioni R, Hurlbert M, et al. "Estimation of the Number of Women Living with Breast Cancer in the United States." Cancer, Epidemiology, Biomarkers and Prevention. 2017;26(6):809-815. DOI:10.1158/1055-9965.EPI-16-0889
National Cancer Institute: "Study estimates number of U.S. women living with breast cancer." Posted May 18, 2017.
Disclosure
FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
This article is relevant for:
People with advanced cancers
This article is also relevant for:
men with breast cancer
people with triple negative breast cancer
people with ER/PR + cancer
people with Her2-positive cancer
people with a genetic mutation linked to cancer risk
people with metastatic or advanced cancer
Be part of XRAY:
IN-DEPTH REVIEW OF RESEARCH
Study background:
breast cancer is defined as breast cancer that has spread and formed tumors at distant places in the body. It may be a woman’s initial diagnosis (at 4) or develop as a recurrence after a 1, 2 or 3 breast cancer metastasizes.
Data from a 2017 study (Mariotto, et al.) indicated that over 170,000 women in the U.S. are living with breast cancer (and there are also several hundred men with breast cancer). Five-year survival rates for breast cancer patients have increased. For ages 18-49, that rate rose from 18% between 1992-1994 to 36% between 2005-2012. During the same time, average survival for women ages 15-49 whose first diagnosis was breast cancer increased from 22.3 months to 38.7 months. Average survival time for women ages 50-64 whose first diagnosis was breast cancer increased from 19.1 months to 29.7 months.
Despite longer life spans after diagnosis, many deaths due to breast cancer still occur annually. Based on Mariotto’s study, only about 17% of women with living with breast cancer have survived more than 10 years. breast cancer can be difficult to treat because cancer cells spread to many parts of the body and often resist standard treatment. Finding new approaches or treatments to slow, halt or reverse cancer growth continues to be an active area of research.
One promising technique for treating cancer is adoptive cell therapy (ACT), also known as adoptive transfer. Researchers extract a patient’s own tumor-infiltrating lymphocytes (TILs); these are unique immune cells that can recognize and attack her tumor cells. These TILs are then grown to vastly larger numbers in the lab and then they are reintroduced into the patient.
Adoptive cell transfer has been used successfully with melanoma and colorectal cancer. Approximately 50% of patients with melanoma who were treated with ACT have shown complete remission. Some types of ACT involve genetically modifying immune cells to boost their effectiveness against cancer cells. In this study, however, the patient’s cells were selected and allowed to multiple in the lab, but they were not genetically modified.
This study is very important because it is the first successful application of T-cell for breast cancer. It holds hope of a new treatment approach that resulted in complete remission of one woman's breast cancer. Such a complete positive result is highly unusual.
Researchers of this study wanted to know: If treatment with a patient's own immune cells would lead to tumor remission.
Population(s) looked at in the study:
This research is a case study of a 49-year-old woman with advanced breast cancer and an exceptionally effective treatment. Originally diagnosed at age 39 with in her left breast, she then had a modified radical mastectomy. She was in remission for 10 years before being diagnosed again with ER+, HER2- breast cancer with tumors in multiple locations, including several , her right breast and left chest wall. She then had several types of chemotherapy and endocrine therapies to treat her cancer that did not halt growth of her tumors.
Study findings:
This study approach is based on —stimulating the body's own defense system to attack tumor cells. This happens naturally to some extent, but as cancer grows, a person’s immune system becomes overwhelmed and is less able to respond.
In this study, researchers collected two types of cells from the patient: tumor cells from a in the right breast and immune cells from the patient's blood. First, they identified unique proteins on the surface of the tumor cells. (These are different from the proteins of normal cells.) Because not all immune cells are alike, they then looked at the patient’s immune cells to identify the ones that could specifically target the tumor proteins. These selected tumor infiltrating lymphocytes, or TILs, were grown in large numbers in the lab and injected back into the patient, greatly strengthening her own body’s defense against her cancer.
The result was surprisingly effective: 6 weeks after treatment her tumors were reduced in size by 51%, and by 22 months after treatment, the masses in the woman's chest wall, right breast and were undetectable.
Limitations:
The largest limitation of this study is number of participants—it is a case study of just one patient. Melanoma treated by ACT is effective for 50% of patients treated; however, it is unclear what proportion of breast cancer patients would respond to this therapy. While this woman responded well and is living without detectable cancer, researchers cannot be sure if her response will be typical, whether it will vary, or if it is a fluke. This is part of an ongoing clinical trial and data from additional participants may be available in the near future.
Whether or not ACT is safe and effective is still unknown. Patients with other cancers who have been treated with ACT have experienced side effects. This patient experienced low blood phosphate levels, a high fever (associated with immune cell depletion), and other treatable major side effects during ACT. But the ACT did not appear to adversely affect her normal tissue. It is too early to know if other unintended side effects would occur when more patients are treated using this technique.
Another limitation of this study is that as part of the procedure, the patient was also treated briefly with the agent pembrolizumab once before ACT and three times after ACT. Pembrolizumab is considered a checkpoint block that can halt cancer cell growth to allow the immune system to attack the cancer more effectively. It is possible that the positive effects observed are due to this drug rather than the ACT treatment. However, historically, pembrolizumab does not have a significant effect on ER+ tumors like those in this patient. Furthermore, when researchers examined the tumor cells of this particular patient, the protein recognized by pembrolizumab was not present. Therefore, it seems unlikely that this drug accounts for the remission observed (although it may aid ACT effectiveness). Further ACT testing without this drug is needed to clarify this issue.
The patient treated is a younger woman (age 49) who does not have a hereditary mutation in a breast cancer predisposition gene. Whether or not her result will apply to women with hereditary mutations is unclear.
Conclusions:
This is an exciting and promising new technique. Much more data is needed to determine its safety and effectiveness and its potential limitations or side effects.
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Posted 8/16/18
The National Comprehensive Cancer Network (NCCN) guidelines for the treatment of advanced or ER-positive breast cancer include the following:
Genetic testing
- All people diagnosed with breast cancer meet guidelines for genetic counseling and testing.
NCCN preferred treatment options
The NCCN lists the following preferred treatments for ER-positive and breast cancer:
- for people with or mutations:
- Lynparza () or () for people with an inherited or mutation.
- therapy
- A combination of hormonal therapy (aromatase inhibitor or Fulvestrant) + with a CDK4/6 inhibitor:
- abemaciclib (Verzenio), palbocicib (Ibrance) or ribociclib (Kisqali).
- A combination of hormonal therapy (aromatase inhibitor or Fulvestrant) + with a CDK4/6 inhibitor:
- For second-, third- or later lines of therapy:
- A combination of hormonal therapy (aromatase inhibitor or Fulvestrant) plus with a CDK4/6 inhibitor for people who have not previously received a CDK4/6 inhibitor.
- Enhertu (trastuzumab deruxtecan) for people with HER2-low ( 1+ or 2+) tumors, who received chemotherapy for disease and whose cancer no longer responds to hormonal therapy.
- Piqray (apelisib) for cancers that test positive for a PIK3CA mutation.
- Oserdu (elacestrant) for , cancers that test positive for an ESR1 mutation.
- Lynparza () or () for BRCA1/BRCA2 for tumors with a or mutation.
- A combination of everolimus and hormonal therapy.
- Hormonal therapy alone.
- Trodelvy (sacituzumab govitecan-hziy) for , after prior treatment, including hormone therapy, a CDK4/6 inhibitor and at least two lines of chemotherapy (including a taxane).
Updated: 03/21/2023
- What is the best treatment approach for my type of cancer?
- Am I eligible for the clinical trial covered in this review?
- Am I eligible for any other clinical trials?
- should I have my tumor tested for biomarkers?
- What are the risks and potential benefits of participating in a clinical trial?
The following studies look at treatment for people with ER-positive breast cancer.
- NCT04673448: Combining the Dostarlimab and Niraparib for Advanced or Breast, Ovarian or Pancreatic Cancer with an Inherited or Tumor Mutation. This study is looking at the effectiveness of combining the , and the dostarlimab for treating people with an inherited mutation (found with genetic testing) or a tumor mutation (found through tumor testing) who have advanced breast, pancreatic or ovarian cancer.
- NCT05501886: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or HR+/HER2- Breast Cancer (VIKTORIA-1). This study is looking at the efficacy and safety of the selective receptor degrader (SERD) gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.
- NCT04975308: A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3). This study will evaluate the efficacy and safety of the selective receptor degrader (SERD) imlunestrant, how it works compared to standard hormone therapy, and how well imlunestrant with abemaciclib works compared to imlunestrant in participants with breast cancer that is ER-positive and .
- NCT05306340: A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With Exemestane Plus Everolimus in Participants With Receptor-Positive, , Locally Advanced or Breast Cancer (evERA Breast Cancer). This study will evaluate the efficacy and safety of the selective receptor degrader (SERD) giredestrant, plus everolimus compared with exemestane plus everolimus in people with receptor ER-positive, locally advanced or breast cancer who have had previous treatment with a CDK4/6 inhibitor and hormone therapy.
- NCT03344965: Expanded - Treating Breast Cancer in People without gBRCA Mutations. This study will look at whether is also effective for treating breast cancer in people who do not have an inherited mutation. The study is enrolling people with an in or an acquired (tumor) mutation in or .
- NCT03685331: , Palbociclib and Fulvestrant for BRCA-Associated, ER/PR+/HER2-Negative Breast Cancer. This study is looking at the side effects and best dose of palbociclib when given with and fulvestrant for people with HR+/HER2-negative mBC who have a or mutation.
- NCT04072952: ARV-471 Alone and in Combination With Palbociclib in Patients With ER+/HER2- Locally Advanced or Breast Cancer. This is a dose escalation and expansion study to learn the safety and tolerability of ARV-471 alone and combined with palbociclib in people with ER+/HER2- locally advanced or breast cancer who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.
- NCT04448886: Sacituzumab Govitecan +/- Pembrolizumab In HR+ / - MBC. This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in HR+/HER2- breast cancer.
- NCT04563507: Combined Immunotherapies in ER+ Breast Cancer. Patients receiving standard therapy for HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each lesion.
- NCT04895358: Pembrolizumab Plus Chemotherapy Versus Plus Chemotherapy for HR+/HER2- Inoperable or Breast Cancer (KEYNOTE-B49). The study will look at the safety and efficacy of pembrolizumab plus chemotherapy compared to chemotherapy alone in the treatment of HR+/HER2- locally recurrent inoperable or breast cancer.
Other clinical trials for people with breast cancer can be found here.
Updated: 12/22/2023
The following organizations offer peer support services for people with, or at high risk for breast cancer:
- FORCE peer support:
- Our Message Boards allow people to connect with others who share their situation. Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Our Peer Navigation Program will match you with a volunteer who shares your mutation and situation.
- Connect online with our Private Facebook Group.
- Join our virtual and in-person support meetings.
- Other organizations that offer breast cancer support:
Updated: 05/07/2024
Who covered this study?
LA Times
"I have definitely hit the jackpot." Advanced breast cancer disappears after new immunotherapy This article rates 5.0 out of 5 stars
U.S. News & World Report
Breakthrough therapy seems to rid woman of advanced breast cancer This article rates 4.5 out of 5 stars
Health.com
This woman's terminal breast cancer disappeared after immunotherapy. Here's why that's such a big deal This article rates 4.0 out of 5 stars
PBS
New Breast Cancer Therapy is a "Win for Society" This article rates 3.5 out of 5 stars
Fox News
Florida woman beats terminal breast cancer with new therapy This article rates 3.5 out of 5 stars
NY Post
Cancer patient given just 3 months to live is cured by experimental treatment This article rates 3.0 out of 5 stars