Clinical trial • Phase III • Oncology

ANASTROZOLE for Breast cancer (node-positive, hormone receptor-positive, HER2-negative)

Phase III trial of ANASTROZOLE for Breast cancer (node-positive, hormone receptor-positive, HER2-negative).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer (node-positive, hormone receptor-positive, HER2-negative)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-09-2024
First CTIS Authorization Date
10-10-2024

Trial design

Randomised, comparator arms include chemotherapy agents: paclitaxel (intravenous infusion; max daily dose 100 mg/m2 stated), docetaxel (intravenous; max daily dose 75 mg/m2 stated), cyclophosphamide (intravenous; max daily dose 600 mg/m2 stated), fluorouracil (intravenous; max daily dose 600 mg/m2 stated), epirubicin (intravenous; max daily dose 90 mg/m2 stated), doxorubicin (intravenous; max daily dose 75 mg/m2 stated). endocrine therapy agents (used as test/standard adjuvant endocrine therapy) include anastrozole (oral; max daily dose 1 mg stated), letrozole (oral; max daily dose 2.5 mg stated), exemestane (oral; max daily dose 25 mg stated), and tamoxifen (oral; max daily dose 20 mg stated). specific dosing schedules are not detailed in the metadata.-controlled Phase III trial in Spain.

Randomised
Yes
Comparator
Comparator arms include chemotherapy agents: PACLITAXEL (intravenous infusion; max daily dose 100 mg/m2 stated), DOCETAXEL (intravenous; max daily dose 75 mg/m2 stated), CYCLOPHOSPHAMIDE (intravenous; max daily dose 600 mg/m2 stated), FLUOROURACIL (intravenous; max daily dose 600 mg/m2 stated), EPIRUBICIN (intravenous; max daily dose 90 mg/m2 stated), DOXORUBICIN (intravenous; max daily dose 75 mg/m2 stated). Endocrine therapy agents (used as test/standard adjuvant endocrine therapy) include ANASTROZOLE (oral; max daily dose 1 mg stated), LETROZOLE (oral; max daily dose 2.5 mg stated), EXEMESTANE (oral; max daily dose 25 mg stated), and TAMOXIFEN (oral; max daily dose 20 mg stated). Specific dosing schedules are not detailed in the metadata.
Target Sample Size
792

Eligibility

Recruits 792 No vulnerable populations selected. All participants must provide written informed consent in accordance with institutional and federal guidelines ("All patients must be informed of the investigational nature of this study and must sign and give written informed consent"). Only females ≥18 years are eligible; men are excluded. No assent procedures are specified..

Pregnancy Exclusion
Patients must not be pregnant or nursing due to the possibility of harm to a fetus or nursing infant from this treatment regimen. Women of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of ?reproductive potential? if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
Vulnerable Population
No vulnerable populations selected. All participants must provide written informed consent in accordance with institutional and federal guidelines ("All patients must be informed of the investigational nature of this study and must sign and give written informed consent"). Only females ≥18 years are eligible; men are excluded. No assent procedures are specified.

Inclusion criteria

  • {"criterion_text":"- Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2\n- Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed\n- Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph nodes dissection (ALND).\n- Patients must not have inflammatory breast cancer and must not have metastatic disease. Patients with a prior diagnosis of DCIS are eligible if they received mastectomy alone (no therapeutic radiation, intraoperative radiation or endocrine therapy). Radiation in the opposite breast is acceptable. Partial breast irradiation (including brachytherapy) is not allowed.\n- Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy (with or without planned postmastectomy radiation). Patients must have clear margins (as per local institutional guidelines).\n- Registration of patients who have not yet undergone Oncotype DX® screening must occur no later than 56 days after definitive surgery. (For all patients, Step 2 Registration must occur within 84 days after definitive surgery.) If the Oncotype DX® Recurrence Score is already known and is 25 or less, the patient must be registered to Step 2 immediately following Step 1 registration. If the Oncotype DX® Recurrence Score is already known and is greater than 25, the patient is ineligible.\n- Patients must be females > or = 18 years of age. As the Oncotype DX® Recurrence Score has not been validated in men with breast cancer, men are not eligible for this study\n- Patients must have a complete history and physical examination within 28 days prior to registration\n- Patients must have a performance status of 0-2 by Zubrod criteria\n- Patients must be able to receive taxane and/or anthracycline based chemotherapy.\n- Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration.\n- Patients must not require chronic treatment with systemic steroids (inhaled steroids are allowed) or other immunosuppressive agents\n- Patients must not have received an aromatase inhibitor (AI) or a selective estrogen receptor modulator (SERM) such as tamoxifen or raloxifene within 5 years prior to registration.\n- Patients must not be pregnant or nursing due to the possibility of harm to a fetus or nursing infant from this treatment regimen. Women of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of ?reproductive potential? if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures\n- No other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years\n- The Quality of Life and Economic Substudy is permanently closed to accrual effective 12/1/12. Patients who consented to QOL prior to 12/1/12 should continue to complete QOL forms per their expectation report.\n- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines."}

Exclusion criteria

  • {"criterion_text":"- Patients must not have inflammatory breast cancer and must not have metastatic disease. Patients with a prior diagnosis of DCIS are eligible if they received mastectomy alone (no therapeutic radiation or endocrine therapy). Radiation in the opposite breast is acceptable. Partial breast irradiation (including brachytherapy) is not allowed\n- Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Invasive Recurrence","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Invasive Disease-Free Survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Distant Disease-Free Survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Local Disease-Free Interval.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall Survival","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
792
Recruitment Window Months
241
Consent Approach
Written informed consent required from each participant ("must sign and give written informed consent in accordance with institutional and federal guidelines"). Consent forms exist for first and second steps (documents: "L1_SIS and ICF_First step", "L1_SIS and ICF_Second step"). Only adults (females ≥18 years) may consent; no assent materials or procedures for minors are described. Spanish translations of trial materials are present (public title and full title translations into Spanish).

Geography

Total Number Of Sites
21
Total Number Of Participants
792

Spain

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
21-07-2025
Processing Time Days
403
Number Of Sites
21
Number Of Participants
792

Sites

Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Begoña Bermejo De Las Heras
Contact Person Email
begobermejo@gmail.com
Site Name
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Department Name
Oncology
Contact Person Name
Ana Medina Colmenero
Contact Person Email
ensayos.clinicos@cog.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Cristina Arqueros Nuñez
Contact Person Email
oncologia@santpau.cat
Site Name
Hospital Universitario Infanta Cristina
Department Name
Oncology
Contact Person Name
Coralia Bueno Muiño
Site Name
Consorcio Hospitalario Provincial De Castellon
Department Name
Oncology
Contact Person Name
Eduardo Martinez De Dueñas
Contact Person Email
eecc@hospitalprovincial.es
Site Name
Hospital Universitario Donostia
Department Name
Oncology
Contact Person Name
Isabel Manuela Alvarez Lopez
Site Name
Fundacion Onkologikoa Fundazioa
Department Name
Oncology
Contact Person Name
Ainhara Lahuerta Martínez
Contact Person Email
alahuerta@onkologikoa.org
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Noelia Martinez Jañez
Contact Person Email
oncologia.hrc@salud.madrid.org
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Montserrat Muñoz Mateu
Contact Person Email
mmunoz@clinic.cat
Site Name
Hospital San Pedro De Alcantara
Department Name
Oncology
Contact Person Name
Santiago Gonzalez Santiago
Contact Person Email
ucancer.hspa@salud-juntaex.es
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Mireia Margeli Vila
Contact Person Email
mmargeli@iconcologia.net
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Miguel Gil Gil
Contact Person Email
ico@iconcologia.net
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Sara López-Tarruella Cobo
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
Angel Guerrero Zotano
Contact Person Email
oncologia@fivo.org
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Contact Person Name
Raquel Andres Conejero
Contact Person Email
umac.hcu@salud.aragon.es
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Oncology
Contact Person Name
Antonio Anton Torres
Contact Person Email
aantont@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Contact Person Name
Emilio Alba Conejo
Contact Person Email
emilio.alba@ibima.eu
Site Name
Hospital General Universitario De Albacete
Department Name
Oncology
Contact Person Name
Encarna Adrover Cebrián
Contact Person Email
eadrover@sescam.jccm.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Manuel Ruiz Borrego
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Sonia Del Barco Berron
Contact Person Email
sdelbarco@iconcologia.net
Site Name
Hospital Universitario De Toledo
Department Name
Oncology
Contact Person Name
Juan David Cardenas
Contact Person Email
juandacardenas@hotmail.com

Sponsor

Primary sponsor

Full Name
Fundacion Grupo Espanol De Investigacion En Cancer De Mama
Organisation Type
Patient organisation/association
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
ANASTROZOLE
Active Substance
ANASTROZOLE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
1 mg (maxDailyDoseAmount)
Investigational Product Name
TAMOXIFEN
Active Substance
TAMOXIFEN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
20 mg (maxDailyDoseAmount)
Investigational Product Name
EXEMESTANE
Active Substance
EXEMESTANE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
25 mg (maxDailyDoseAmount)
Investigational Product Name
LETROZOLE
Active Substance
LETROZOLE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
2.5 mg (maxDailyDoseAmount)
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Maximum Dose
100 mg/m2 (maxDailyDoseAmount)
Investigational Product Name
DOCETAXEL
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Maximum Dose
75 mg/m2 (maxDailyDoseAmount)
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Maximum Dose
600 mg/m2 (maxDailyDoseAmount)
Investigational Product Name
FLUOROURACIL
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Maximum Dose
600 mg/m2 (maxDailyDoseAmount)
Investigational Product Name
EPIRUBICIN
Active Substance
EPIRUBICIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Maximum Dose
90 mg/m2 (maxDailyDoseAmount)
Investigational Product Name
DOXORUBICIN
Active Substance
DOXORUBICIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Maximum Dose
75 mg/m2 (maxDailyDoseAmount)
Combination Treatment
Yes

Related trials

Other published trials that may interest you.