Breast Cancer, Early Breast Cancer Clinical Trial
— CAMBRIA-1Official title:
CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
| Status | Recruiting |
| Enrollment | 4300 |
| Est. completion date | May 29, 2036 |
| Est. primary completion date | April 19, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility | Inclusion Criteria: - Women and Men, =18 years at the time of screening (or per national guidelines) - Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol. - Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy - Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor) - Eastern Cooperative Oncology Group (ECOG) performance status of = 1 - Adequate organ and marrow function Exclusion criteria: - Inoperable locally advanced or metastatic breast cancer - Pathological complete response following treatment with neoadjuvant therapy - History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered at very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation - Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance - Known LVEF <50% with heart failure NYHA Grade =2. - Mean resting QTcF interval >480 ms at screening - Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions - Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab) - Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant - Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding - Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists, that would preclude the patient from receiving any LHRH agonist |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Capital Federal | |
| Argentina | Research Site | Ciudad Autónoma Buenos Aires | |
| Argentina | Research Site | Ciudad Autonoma de Buenos Aires | |
| Argentina | Research Site | Ciudad de Buenos Aires | |
| Argentina | Research Site | Cordoba | |
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| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Izmir | |
| Turkey | Research Site | Izmir | |
| Turkey | Research Site | Izmir | |
| Turkey | Research Site | Samsun | |
| United Kingdom | Research Site | Brighton | |
| United Kingdom | Research Site | Burton-on-Trent | |
| United Kingdom | Research Site | Cambridge | |
| United Kingdom | Research Site | Derby | |
| United Kingdom | Research Site | Edinburgh | |
| United Kingdom | Research Site | Guildford | |
| United Kingdom | Research Site | Ipswich | |
| United Kingdom | Research Site | Keighley | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Oxford | |
| United Kingdom | Research Site | Peterborough | |
| United Kingdom | Research Site | Stoke on Trent | |
| United Kingdom | Research Site | Sutton | |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Anchorage | Alaska |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Baton Rouge | Louisiana |
| United States | Research Site | Beverly Hills | California |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Brewer | Maine |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Chandler | Arizona |
| United States | Research Site | Charleston | West Virginia |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Chattanooga | Tennessee |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clairton | Pennsylvania |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Columbus | Georgia |
| United States | Research Site | Concord | California |
| United States | Research Site | Corona | California |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Decatur | Illinois |
| United States | Research Site | Denton | Texas |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Dothan | Alabama |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | East Lansing | Michigan |
| United States | Research Site | East Syracuse | New York |
| United States | Research Site | Elmhurst | Illinois |
| United States | Research Site | Fairfax | Virginia |
| United States | Research Site | Farmington | New Mexico |
| United States | Research Site | Fort Mitchell | Kentucky |
| United States | Research Site | Fort Myers | Florida |
| United States | Research Site | Fort Wayne | Indiana |
| United States | Research Site | Fountain Valley | California |
| United States | Research Site | Frederick | Maryland |
| United States | Research Site | Gainesville | Florida |
| United States | Research Site | Glenn Dale | Maryland |
| United States | Research Site | Greenbrae | California |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Hartford | Connecticut |
| United States | Research Site | Honolulu | Hawaii |
| United States | Research Site | Hot Springs National Park | Arkansas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Hyannis | Massachusetts |
| United States | Research Site | Independence | Missouri |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | Laconia | New Hampshire |
| United States | Research Site | Lancaster | South Carolina |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Lincoln | Nebraska |
| United States | Research Site | Los Alamitos | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Lynchburg | Virginia |
| United States | Research Site | Madison | Wisconsin |
| United States | Research Site | Miami Beach | Florida |
| United States | Research Site | Midlothian | Virginia |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Morgantown | West Virginia |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Hyde Park | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Palo Alto | California |
| United States | Research Site | Park Ridge | Illinois |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Plantation | Florida |
| United States | Research Site | Port Saint Lucie | Florida |
| United States | Research Site | Providence | Rhode Island |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Reading | Pennsylvania |
| United States | Research Site | Reston | Virginia |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rocky Mount | North Carolina |
| United States | Research Site | Royal Oak | Michigan |
| United States | Research Site | Saint Augustine | Florida |
| United States | Research Site | Saint Petersburg | Florida |
| United States | Research Site | Saint Petersburg | Florida |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | Santa Fe | New Mexico |
| United States | Research Site | Scarborough | Maine |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Silver Spring | Maryland |
| United States | Research Site | Sioux Falls | South Dakota |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | State College | Pennsylvania |
| United States | Research Site | Stony Brook | New York |
| United States | Research Site | Tallahassee | Florida |
| United States | Research Site | Towson | Maryland |
| United States | Research Site | West Palm Beach | Florida |
| United States | Research Site | White Plains | New York |
| United States | Research Site | Whittier | California |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | Winter Haven | Florida |
| United States | Research Site | Youngstown | Ohio |
| Vietnam | Research Site | Hanoi | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Ho Chi Minh city | |
| Vietnam | Research Site | Hue |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Vietnam, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Serbia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Invasive breast cancer-free survival (IBCFS) | IBCFS is defined as time from randomisation until date of first occurrence of:
Invasive ipsilateral breast tumour recurrence (invasive IBTR) Locoregional invasive breast cancer recurrence Distant recurrence Invasive contralateral breast cancer Death attributable to any cause. |
Up to 10 years | |
| Secondary | Invasive disease-free survival (IDFS) | IDFS is defined as time from randomisation until date of first occurrence of one of the following events:
Invasive ipsilateral breast tumor recurrence (invasive IBTR) Locoregional invasive breast cancer recurrence Distant recurrence Invasive contralateral breast cancer Second primary non-breast invasive cancer Death attributable to any cause. |
Up to 10 years | |
| Secondary | Distant relapse-free survival (DRFS) | DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first. | Up to 10 years | |
| Secondary | Overall survival (OS) | OS is defined as time from randomisation until death from any cause. | Up to 10 years | |
| Secondary | Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0) | Until 28 days after the final dose of study treatment (up to 5 years) | ||
| Secondary | Absolute and percent change from baseline in Clinical Laboratory Parameters | Until 28 days after the final dose of study treatment (up to 5 years) | ||
| Secondary | Absolute and percent change from baseline in Vital Sign Parameters | Until 28 days after the final dose of study treatment (up to 5 years) | ||
| Secondary | Number of participants with abnormal physical examinations | Until 28 days after the final dose of study treatment (up to 5 years) | ||
| Secondary | Change from baseline of arthralgia as measured by the EORTC-IL-194 (European Organisation for Research and Treatment of Cancer) item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) | Until 28 days after the final dose of study treatment (up to 5 years) | ||
| Secondary | Change from baseline of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) | Until 28 days after the final dose of study treatment (up to 5 years) | ||
| Secondary | Change from baseline of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) | Until 28 days after the final dose of study treatment (up to 5 years) | ||
| Secondary | Proportion of patients experiencing each level of symptomatic AEs of arthralgia as measured by the EORTC-IL-194 item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) | Until 28 days after the final dose of study treatment (up to 5 years) | ||
| Secondary | Proportion of patients experiencing each level of symptomatic AEs of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) | Until 28 days after the final dose of study treatment (up to 5 years) | ||
| Secondary | Proportion of patients experiencing each level of symptomatic AEs of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) | Until 28 days after the final dose of study treatment (up to 5 years) | ||
| Secondary | Change from baseline and TTD (time to deterioration ) of health-related QoL (quality of life) as measured by the 2 global QoL items from the EORTC-QLQ-C30 items 11 and 12. EORTC-QLQ-C30 uses 0 - 4 scale (higher score is worse) | Until 28 days after the final dose of study treatment (up to 5 years) | ||
| Secondary | Pharmacokinetics (PK) | • Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration) | Until 6 months from treatment start |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05952557 -
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
|
Phase 3 | |
| Completed |
NCT02443467 -
A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer
|
N/A |