Clinical trial NCT04603820: Registry Study of Pregnancy and Breast Cancer
Official title: An Ambispective Observational Registry Study of Pregnancy and Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer and Pregnancy
Keywords: Pregnancy
Gestational breast cancer
Fertility preservation technique
Breast Cancer
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer in any of these three situations:

1. Patients with gestational breast cancer, defined as breast cancer diagnosed during pregnancy, breastfeeding or up to a year after delivery.
2. Patients who become pregnant after a breast cancer diagnosis.
3. Patients with breast cancer who have followed any fertility preservation technique prior to the start of breast cancer treatment.

Brief summary: An ambispective observational registry study of pregnancy and breast cancer

Detailed description: A multicenter, observational, non-post-marketing (non-PMS), ambispective (retrospective and prospective from the registry opening) study which will enroll patients with breast cancer in any of these three situations:

1. Patients with gestational breast cancer, defined as breast cancer diagnosed during pregnancy, breastfeeding or up to a year after delivery.
2. Patients who become pregnant after a breast cancer diagnosis.
3. Patients with breast cancer who have followed any fertility preservation technique prior to the start of breast cancer treatment.

It is estimated a minimum recruitment period of approximately 3 years from the study activation. The study will remain open as long as possible in order to collect as much information as possible. GEICAM will actively search for funding for this.

Patients may also be concurrently enrolled in an interventional clinical trial. This observational registry study of pregnancy and breast cancer that collects significant data obtained from standard clinical practice, regarding the clinical characteristics of patients with breast cancer in any of the three situations described above. These data will allow the performance of both descriptive and exploratory analyses in order to evaluate the associations between different breast cancer subtypes and risk factors observed.

Finally, this study will collect high quality molecular data derived from the analysis of biological samples (paraffin-embedded tumor and peripheral blood samples) to reach a better understanding of the biological mechanisms involved in breast cancer in relation to pregnancy.

No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study.

Eligibility criteria: Inclusion Criteria:

1. The patient should have signed and dated the informed consent form (ICF). The enrollment of patients who have died is allowed.
2. Women aged ≥ 18 years.
3. Patients in one of the following situations:

   * Patients with breast cancer diagnosis during pregnancy, breastfeeding or within the year after delivery.
   * Patients with breast cancer who become pregnant after treatment.
   * Patients with breast cancer who were subjected to any fertility preservation method prior to the start of breast cancer treatment.
4. The patients referred to in the previous section and the patients who meet these characteristics prospectively could be enrolled retrospectively upon registry opening.
5. All cases diagnosed at the same site may be included. In order to prevent duplications, in case the patient followed her treatment and follow-up at another site, she will be enrolled as per the site where the diagnosis was made, requesting information of the treatment and progression, when possible.
6. Availability of clinical, epidemiological and progress data.

Exclusion Criteria:

Patients who do not wish to participate in the study for any reason could not be included in the study.

Primary outcomes:
measure: Number of participants with breast cancer diagnosis during the gestation, breastfeeding, first year after the delivery (not during breastfeeding period), after a pregnancy and followed by any fertility preservation method before the anticancer treatment
timeFrame: Baseline visit
measure: Race of participants with breast cancer diagnosis during the gestation, breastfeeding, first year after the delivery (not during breastfeeding period), after a pregnancy and followed by any fertility preservation method before the anticancer treatment
timeFrame: Baseline visit
measure: Age of participants with breast cancer diagnosis during the gestation, breastfeeding, first year after the delivery (not during breastfeeding period), after a pregnancy and followed by any fertility preservation method before the anticancer treatment
timeFrame: Baseline visit
Secondary outcomes:
measure: Clinicopathological characteristics of cancer: Tumor size
timeFrame: 3 years
measure: Clinicopathological characteristics of cancer: lymph node condition
timeFrame: 3 years
measure: Clinicopathological characteristics of cancer: metastasis presence
timeFrame: 3 years
measure: Clinicopathological characteristics of cancer: histopathological differentiation degree
timeFrame: 3 years
measure: Clinicopathological characteristics of cancer: hormonal receptor status
timeFrame: 3 years
measure: Clinicopathological characteristics of cancer: human epidermal growth factor receptor 2 (HER2) condition
timeFrame: 3 years
measure: Clinicopathological characteristics of cancer: Ki67 proliferation index
timeFrame: 3 years
measure: Clinicopathological characteristics of cancer: BRCA1 and 2 mutations
timeFrame: 3 years
measure: Disease-free survival (DFS) of pregnant women with breast cancer, pregnant patients after breast cancer and patients who have undergone techniques for the preservation of fertility.
timeFrame: 3 years
measure: Event-free survival (EFS) of pregnant women with breast cancer, pregnant patients after breast cancer and patients who have undergone techniques for the preservation of fertility.
timeFrame: 3 years
measure: Progression-free survival (PFS) of pregnant women with breast cancer, pregnant patients after breast cancer and patients who have undergone techniques for the preservation of fertility.
timeFrame: 3 years
measure: Overall survival (OS) of pregnant women with breast cancer, pregnant patients after breast cancer and patients who have undergone techniques for the preservation of fertility.
timeFrame: 3 years
measure: Correlation of the molecular profiles identified with the patients' clinicopathological and epidemiological characteristics and their disease evolution.
timeFrame: 3 years
measure: Association between gestational breast cancer and a specific genotype or gene expression profile.
timeFrame: 3 years
measure: Number of patients with breast cancer managed to get pregnant, spontaneously or through in vitro fertilization (IVF) methods
timeFrame: 3 years
measure: Number of patients with breast cancer that have followed fertility preservation techniques and what type of techniques were used.
timeFrame: 3 years
measure: Enumerate the potential risks of fertility preservation techniques in women with breast cancer.
timeFrame: 3 years
measure: Pregnancy outcome from women diagnosed with gestational breast cancer or women with breast cancer diagnosis who became pregnant.
timeFrame: 3 years
measure: Progress of the babies born from women diagnosed with gestational breast cancer or women with breast cancer diagnosis who became pregnant.
timeFrame: 3 years
Other outcomes:
measure: Potential relationship of clinical activity biomarkers and the probability of developing gestational breast cancer or having a relapse after the pregnancy
timeFrame: 3 years
Locations:
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Terrassa
state: Barcelona
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
state: Bizkaia
city: Palma De Mallorca
country: Spain
facility: Hospital Unviersitari Son Espases
state: Islas Baleares
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Nuestra Señora de la Candelaria
state: Islas Canarias
city: A Coruña
country: Spain
facility: Complejo Hospitalario de Galicia (CHUAC)
state: La Coruña
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Doctor Negrín
state: Las Palmas
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Córdoba
country: Spain
facility: Complejo Hospitalario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud de Toledo
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fè
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Instituto Valenciano de Oncología, Valencia, España
name: Study Director
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Reina Sofía de Córdoba, Córdoba, España
name: Study Director
role: STUDY_DIRECTOR
affiliation: Hospital Clínico Universitario de Valencia, Valencia, España
name: Study Director
role: STUDY_DIRECTOR
affiliation: Centro Nacional de Epidemiología. Instituto de Salud Carlos III, Madrid, España
name: Study Director
role: STUDY_DIRECTOR
References: