Menopause Drug Reduces Breast Cancer Growth In Clinical Trial
A drug used to relieve the debilitating symptoms of menopause may also be reducing the risk of invasive breast cancer, a new clinical trial by Northwestern University suggests.
Almost 60,000 women a year are diagnosed with a contained form of breast cancer that can indicate a higher risk of developing invasive tumors later in life.
The non-invasive cancer is typically detected during routine mammograms, accounts for up to 25 percent of all breast cancer diagnoses, and has a 98 percent recovery rate after 10 years when removed by surgery.
However, to increase their chance of remaining cancer-free many patients also undergo treatments like radiation and hormone therapy following surgery. These treatments often have debilitating side effects.
The phase two clinical trial recruited 141 postmenopausal women who have a form of contained breast cancer called ductal carcinoma tumors. Half of them were given a medication for managing symptoms of menopause called Duavee; others were administered a placebo for the month between diagnosis and breast cancer surgery.
Duavee is composed of estrogen hormones and bazedoxifene – a molecule that either promotes or dampens the use of estrogens in the body, depending on the type of tissue it is in. This estrogen receptor modifier is also used to help treat osteoporosis.
Those who took the drug had notably less cell growth in their breast tissue by their surgery date. There was also "no impact on quality of life compared to placebo."
"What excites me most is that a medication designed to help women feel better during menopause may also reduce their risk of invasive breast cancer," says Northwestern University surgeon Swati Kulkarni.
Significantly, trial participants taking Duavee did not experience the intolerable side effects associated with other cancer drugs. Rather, it tends to increase the quality of life in people already struggling with menopause.
While larger studies are still needed to confirm Duavee's ability to prevent breast cancer, Kulkarni and team suggest that, for now, those with elevated risk for breast cancer as well as menopausal symptoms would most likely benefit from Duavee.
Especially given women with prior cancer lesions can't resort to hormone treatments to ease their menopause symptoms because they can increase the risk of breast cancer returning.
"These results support consideration that [Duavee] is a safe option to manage menopausal symptoms for women concerned about their risk of developing breast cancer, and provide supportive evidence that [Duavee] may reduce the risk of developing invasive breast cancer," the researchers conclude in their conference abstract.
The trial results have yet to be published but were presented at the American Society of Clinical Oncology's latest annual meeting.
Bowel Cancer in Young People Is Rising – Here's How to Reduce Your Risk
Why Do Some People Need Less Sleep? The Answer Lies in Our Genes.
Regular Exercise Reduces Death From Colon Cancer by 37%, Study Finds
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Associated Press
6 hours ago
- Associated Press
Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer
– This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine – – VERITAC-2 data support vepdegestrant as a potential treatment option in patients with ESR1m ER+/HER2- advanced or metastatic breast cancer – NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc. (NYSE: PFE), for vepdegestrant for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. This submission is based on results from VERITAC-2 (NCT05654623), a global, randomized Phase 3 trial evaluating vepdegestrant versus fulvestrant. 'This milestone comes after an exciting presentation at the American Society of Clinical Oncology's annual meeting,' said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. 'We look forward to the NDA review and to the first ever FDA-approved PROTAC ER degrader potentially being available to patients who could benefit from a much needed, new treatment option.' Vepdegestrant is being jointly developed by Arvinas and Pfizer for the treatment of patients with advanced or metastatic ER+/HER2- breast cancer and was granted fast track designation as a monotherapy by the FDA. Results from the VERITAC-2 study were recently presented in a late-breaking oral presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting and were selected for the ASCO press briefing and for Best of ASCO. Detailed results were also simultaneously published in the New England Journal of Medicine. About the VERITAC-2 Clinical Trial The Phase 3 VERITAC-2 clinical trial ( NCT05654623 ) is a global, randomized trial evaluating the efficacy and safety of vepdegestrant (ARV-471) as a monotherapy compared to fulvestrant in patients with ER+/HER2- advanced or metastatic breast cancer. The trial enrolled 624 patients at sites in 25 countries who had previously received treatment with a CDK4/6 inhibitor plus endocrine therapy. Patients were randomized 1:1 to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. In the trial, 43% of patients (n=270) had ESR1 mutations detected. The primary endpoint was progression-free survival (PFS) in the ESR1-mutation and intent-to-treat populations as determined by blinded independent central review. Overall survival is the key secondary endpoint. About Vepdegestrant Vepdegestrant is an investigational, orally bioavailable PROTAC (PROteolysis TArgeting Chimera) protein degrader designed to specifically target and degrade the estrogen receptor (ER). Vepdegestrant is being developed as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy. About Arvinas Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis TArgeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body's natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit and connect on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: the NDA review and to the first ever FDA-approved PROTAC ER degrader potentially being available to patients who could benefit from a much needed, new treatment option; and vepdegestrant's development as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second line-plus setting. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas' strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'target,' 'goal,' 'potential,' 'will,' 'would,' 'could,' 'should,' 'look forward,' 'continue,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: whether Arvinas and Pfizer will successfully perform their respective obligations under the collaboration between Arvinas and Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant as a monotherapy; whether the VERITAC-2 clinical trial will meet the secondary endpoint for overall survival; risks related to our expectations regarding the potential clinical benefit of vepdegestrant to patients; uncertainties relating to regulatory applications and related filing and approval timelines, including the New Drug Application seeking FDA approval of vepdegestrant and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; whether FDA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of vepdegestrant; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant and other product candidates on current timelines or at all; Arvinas' ability to protect its intellectual property portfolio; Arvinas' reliance on third parties; whether Arvinas will be able to raise capital when needed; whether Arvinas' cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the 'Risk Factors' section of Arvinas' Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas' current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas' views as of any date subsequent to the date of this release. Contacts Investors: Jeff Boyle +1 (347) 247-5089 [email protected] Media: Kirsten Owens +1 (203) 584-0307 [email protected]
Medscape
6 hours ago
- Medscape
Surgery Before or After Chemo for Advanced Ovarian Cancer?
The optimal timing of surgery in patients with resectable advanced ovarian cancer remains controversial. Should these patients receive the standard radical surgery followed by chemotherapy, or could patients do better with chemotherapy before surgery? The long-awaited TRUST trial aimed to settle this question, but the results paint a somewhat mixed picture. Among patients with resectable stage IIIB-IVB ovarian cancer, primary cytoreductive surgery followed by chemotherapy led to a statistically significant 2.4-month median progression-free survival (PFS) benefit over neoadjuvant chemotherapy followed by interval cytoreductive surgery. While the median overall survival was 6 months longer in the upfront surgery group, the difference was not statistically significant. Patients in both groups reported similar quality of life over a 3-year period on a global health survey. 'TRUST is the first randomized controlled trial to show a significant benefit in median PFS without compromising short- or long-term quality of life,' said lead investigator Sven Mahner, MD, with Ludwig Maximilian University Hospital, Munich, Germany, who presented the results at the American Society of Clinical Oncology (ASCO) 2025 annual meeting. Mahner called the PFS and overall survival findings in the upfront surgery group 'excellent' but acknowledged that the primary endpoint of significant overall survival was not met. ASCO discussant Emma Barber, MD, gynecologic oncologist with Northwestern Memorial Hospital, Chicago, was less enthusiastic about the benefits of upfront surgery, given the lack of significant overall survival benefit. Additionally, the upfront surgery group had a higher rate of any complication and more than a twofold higher rate of stoma formation. 'There is upfront toxicity with primary debulking surgery compared to neoadjuvant chemotherapy — even in the highest quality surgical centers,' she said. TRUST Rationale The aim of surgery in advanced ovarian cancer is to prolong patients' remission and improve overall survival while sustaining quality of life, said Mahner. Primary cytoreductive surgery followed by chemotherapy has been considered standard for decades in this patient population. However, there's an alternative strategy — neoadjuvant chemotherapy followed by interval cytoreductive surgery. Several trials have compared upfront surgery with upfront chemotherapy, but limitations in these studies have not helped answer which approach is better. TRUST was designed to evaluate the optimal timing of cytoreductive surgery in patients with resectable advanced ovarian cancer who are fit enough to tolerate radical surgery. Patients received care in cancer centers that used defined surgical quality assurance metrics. Quality criteria were based on the European Training Centre in Gynaecological Oncology certification and included evaluations of cytoreductive surgery in the operating room as well as assessments of surgical proficiency and infrastructure. In addition, participating centers had to have high complete resection rates (at least 50% in upfront surgery for patients with FIGO IIIB-IVB) and high surgical volumes (at least 36 cytoreductive surgeries per year). Patients were randomly assigned and stratified by center and age-Eastern Cooperative Oncology Group (ECOG) combination (ECOG 0 and age ≤ 65 years vs ECOG > 0 and age older than 65 years) to either primary cytoreductive surgery followed by six cycles of intravenous chemotherapy (n = 345) or three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery plus three more cycles of chemotherapy (n = 343). Most patients had FIGO stage IIIc disease, and over 90% had high-grade serous histology. Surgical effort was very high in both treatment groups; the median duration of surgery was 5.5 hours in the primary cytoreductive surgery group and 4.5 hours in the interval cytoreductive surgery group, Mahner noted. High surgical effort led to high complete resection rates — 70% in the primary group and 85% in the interval group — which meant the recommended systemic treatment of carboplatin and paclitaxel could be given in more than 90% of the patients, with a considerable number of patients also receiving bevacizumab or a PARP inhibitor during the course of their disease, Mahner said. Survival Outcomes Overall, 219 (64%) PFS events occurred in the primary cytoreductive surgery group and 253 (74%) in the neoadjuvant chemotherapy group. Median PFS after primary surgery was 22.1 months compared to 19.7 months after interval surgery — a 2.4-month benefit (hazard ratio [HR], 0.80; P = .018). The researchers also conducted a restricted mean survival analysis and found PFS was 31.7 months with primary surgery compared to 26.6 months with neoadjuvant chemotherapy — a 5.1-month benefit ( P = .07). On the overall survival front, the primary surgery group had a 6-month benefit, but the difference was not significant — median overall survival was 54.3 months with primary surgery compared to 48.3 months with interval surgery (HR, 0.89; P = .24). Careful Patient Selection Necessary In subgroup analyses, patients with complete cytoreduction after primary surgery had the best outcomes, with a median PFS of 27.9 months vs 21.8 months with interval surgery (HR, 0.69; P = .0009) and median overall survival of 67.0 months vs 55.0 months (HR, 0.80; P = .0521). In addition, the benefit of primary cytoreductive surgery was most prominent in stage III patients with a median PFS of 26.3 months vs 21.4 months (HR, 0.73; P = .005) and a median overall survival of 63.7 months vs 53.2 months, respectively (HR, 0.84; P = .14). However, patients with stage IV disease did not benefit more from upfront surgery in PFS (HR, 1.01; 95% CI, 0.74-1.38) or overall survival (HR, 0.97; 95% CI, 0.71-1.33). Mahner also noted that 5 years after randomization, 23% of the patients who had primary surgery had no disease progression compared to 11% of the patients who had interval surgery. The complication rate was higher in the primary surgery group at 18% vs 12% after interval surgery. The 30-day post-operative mortality rate was less than 1% in both treatment groups. Patients in both groups reported similar quality of life outcomes. Barber noted that the data suggest that some populations may benefit more from upfront surgery and others may not. 'For example, patients with stage IV disease clearly do not seem to benefit, whereas those with stage III disease seem to show a trend towards improved survival,' she explained. Given the higher upfront toxicity associated with primary debulking surgery, 'selection for primary debulking surgery instead of neoadjuvant chemotherapy should be considered carefully and performed for selected populations,' Barber said.
Newsweek
a day ago
- Newsweek
Cities Most at Risk for Rise in Heart Attacks as Canadian Wildfires Burn
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Some residents of several major cities in the Midwest could face an increased risk of heart attack and stroke as smoke from Canadian wildfires continues to descend into the United States this week. "Exposure to particulate matter air pollution causes inflammation in the lungs. This can manifest as worsening of respiratory symptoms, particularly in people with asthma or chronic obstructive pulmonary disease," Dr. Scott Budinger, the chief of pulmonary and critical care in the Department of Medicine at Northwestern University, told Newsweek. "[E]ven more importantly, exposure to particulate matter air pollution acutely increases the risk of heart attacks or strokes," he added. Why It Matters The widespread drift of wildfire smoke from Canada into U.S. metropolitan areas carries significant public health implications. Medical research has documented an association between exposure to fine particulate pollution (PM2.5) and acute increases in heart attacks, strokes, and other cardiovascular events. Vulnerable groups, particularly people living with coronary artery disease, histories of heart attacks or strokes, and chronic respiratory illness, are at elevated risk. With urban centers housing millions, the threat is not only environmental but medical, affecting emergency room capacities and potentially increasing mortality rates. Previous wildfire smoke events, such as those seen in 2023, have already demonstrated the potential for widespread air quality degradation and related health emergencies across city populations. What To Know Smoke from Canadian wildfires has degraded air quality across the Upper Midwest for over a week. The smoke has even reached the U.S. Gulf Coast, where it had less of an impact on physical health. At least eight states were under air quality alerts on Thursday morning, with the U.S. Environmental Protection Agency (EPA) AirNow map showing the current Air Quality Index as "unhealthy" in areas such as Chicago, Illinois, and Lansing and Grand Rapids, Michigan. This AQI is unhealthy for everyone to breathe. A map from the U.S. EPA's AirNow shows cities with unhealthy air quality as of Thursday morning at 11 a.m. Eastern time. A map from the U.S. EPA's AirNow shows cities with unhealthy air quality as of Thursday morning at 11 a.m. Eastern time. AirNow The less severe but still impactful Unhealthy for Sensitive Groups AQI was much more widespread, stretching across parts of Wisconsin, Illinois, Michigan, Indiana, Ohio, and into the Northeast, including Maine and New York. Wildfire smoke contains high concentrations of PM2.5—fine particulate matter that can enter the lungs and bloodstream. Exposure is linked to worsening symptoms in those with asthma or chronic obstructive pulmonary disease (COPD), but acute cardiovascular risks, including heart attacks and strokes, may be even more pronounced. City populations face greater danger when air pollution is trapped near the surface during stagnant weather conditions. In some instances, people were asked to monitor themselves for symptoms such as coughing during the poor air quality event. If coughs persist for more than seven days or are accompanied by shortness of breath, people should visit their doctor or seek more urgent care if necessary. People are urged to remain indoors and keep their windows closed to prevent exposure. What People Are Saying Dr. Scott Budinger, the chief of pulmonary and critical care in the Department of Medicine at Northwestern University, told Newsweek: "People who have known blockages in their arteries or a history of heart attacks or strokes and people with chronic lung diseases like asthma and COPD should avoid exposure. They should also be vigilant about taking all of the prescribed medications for their disease." Budinger added: "You can reduce the risk of exposure by staying indoors with the windows closed. Indoor levels of particulate matter air pollution are typically much lower than those outside in a heated or air conditioned home or business—as much as 10 times less. For example, it might be better to take a walk in a health club or mall rather than outside if the particulate levels are high." An air quality alert issued in Michigan: "It is recommended that, when possible, you avoid strenuous outdoor activities, especially those with heart disease and respiratory diseases like asthma. Monitor for symptoms such as wheezing, coughing, chest tightness, dizziness, or burning in nose, throat, and eyes. Reduce or eliminate activities that contribute to air pollution, such as outdoor burning, and use of residential wood burning devices." What Happens Next Air quality alerts remained in effect in many cities in the Upper Midwest through the end of the week, with meteorologists forecasting that wildfire smoke could persist for several more days. Public health officials continue to advise at-risk populations in major cities to closely monitor advisories, limit outdoor activities during high-pollution periods, and use indoor air filtration.
