Registry Study of Pregnancy and Breast Cancer (EMBARCAM)

April 12, 2024 updated by: Spanish Breast Cancer Research Group

An Ambispective Observational Registry Study of Pregnancy and Breast Cancer

An ambispective observational registry study of pregnancy and breast cancer

Study Overview

Status

Recruiting

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Albacete, Spain, 02006
        • Recruiting
        • Hospital General Universitario de Albacete
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic I Provincial
      • Cáceres, Spain, 10003
        • Recruiting
        • Hospital San Pedro de Alcantara
      • Córdoba, Spain, 14004
        • Recruiting
        • Complejo Hospitalario Reina Sofía
      • Granada, Spain, 18016
        • Recruiting
        • Hospital Universitario San Cecilio
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Toledo, Spain, 45004
        • Recruiting
        • Hospital Virgen de la Salud de Toledo
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncologia
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
      • Terrassa, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Universitario Mutua de Terrassa
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48013
        • Recruiting
        • Hospital Universitario de Basurto
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain, 07120
        • Recruiting
        • Hospital Unviersitari Son Espases
    • Islas Canarias
      • Santa Cruz De Tenerife, Islas Canarias, Spain, 38010
        • Recruiting
        • Hospital Nuestra Señora de La Candelaria
    • La Coruña
      • A Coruña, La Coruña, Spain, 15009
        • Recruiting
        • Complejo Hospitalario de Galicia (CHUAC)
    • Las Palmas
      • Las Palmas De Gran Canaria, Las Palmas, Spain, 35010
        • Recruiting
        • Hospital Universitario Doctor Negrin
    • Madrid
      • Leganés, Madrid, Spain, 28911
        • Recruiting
        • Hospital Universitario Severo Ochoa
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Clínico Universitario Virgen de la Arrixaca
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Complejo Hospitalario de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline visit

Data for this study will be recorded into the electronic case report form (eCRF) via web using Remote Data Capture (RDC) from Oracle Clinical®. Once patient has signed the ICF or verified that the data of deceased patients can be included, designated site personnel will complete the register of each patient in the eCRF, where an identification number will automatically be assigned.

Data will be recorded in the eCRF at the time of patient enrollment and approximately every year.

Baseline visit
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
Time Frame: Baseline visit

Data for this study will be recorded into the eCRF via web using RDC (Remote Data Capture) from Oracle Clinical®. Once patient has signed the ICF or verified that the data of deceased patients can be included, designated site personnel will complete the register of each patient in the eCRF, where an identification number will automatically be assigned.

Data will be recorded in the eCRF at the time of patient enrollment and approximately every year.

Baseline visit
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
Time Frame: Baseline visit

Data for this study will be recorded into the eCRF via web using RDC (Remote Data Capture) from Oracle Clinical®. Once patient has signed the ICF or verified that the data of deceased patients can be included, designated site personnel will complete the register of each patient in the eCRF, where an identification number will automatically be assigned.

Data will be recorded in the eCRF at the time of patient enrollment and approximately every year.

Baseline visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinicopathological characteristics of cancer: Tumor size
Time Frame: 3 years

Assess the clinicopathological characteristics of cancer in the patients enrolled in the study. For this, it is used the Tumor, Node, Metastasis (TNM) staging system is the most common way that doctors stage breast cancer. Patient scans and tests give some information about the stage of the cancer.

Tumor (T) size describes the size of the tumour. Larger T is associated with inferior survival.

Tumor cannot be assessed (TX): can't be assessed. Tis: ductal carcinoma in situ. T1: tumour is 2 centimetres (cm) across or less. T1mi: tumour is 0.1cm across or less T1a: tumour >0.1 cm but <0.5 cm T1b: tumour >0.5 cm but <1 cm T1c: tumour >1 cm but <2 cm T2: tumour >2 cm but <5 cm across. T3: tumour >5 cm across. T4a: tumour has spread into the chest wall T4b: tumour has spread into the skin and the breast might be swollen T4c: tumour has spread to both the skin and the chest wall T4d: inflammatory carcinoma

3 years
Clinicopathological characteristics of cancer: lymph node condition
Time Frame: 3 years

Assess the clinicopathological characteristics of cancer in the patients enrolled in the study. For this, it is used the Tumor, Node, Metastasis (TNM) staging system is the most common way that doctors stage breast cancer. Patient scans and tests give some information about the stage of the cancer.

Lymph Node (N) conditions describes whether the cancer has spread to the Lymph Nodes (LN). Prognosis is better when cancer has not spread to the LN. The more LN that contain cancer, the poorer prognosis tends to be.

Node cannot be assessed (NX): LN can't be assessed N0: no Cancer Cells (CC) N1: CC in the LN in the armpit but the nodes are not stuck to surrounding tissues.

N2a: CC in the LN in the armpit, which are stuck to each other and to other structures.

N2b: CC in the LN behind the breast bone. N3a: CC in LN below the collarbone. N3b: CC in LN in the armpit and behind the breastbone. N3c: CC in LN above the collarbone.

3 years
Clinicopathological characteristics of cancer: metastasis presence
Time Frame: 3 years

Assess the clinicopathological characteristics of cancer in the patients enrolled in the study. For this, it is used the Tumor, Node, Metastasis (TNM) staging system is the most common way that doctors stage breast cancer. Patient scans and tests give some information about the stage of the cancer.

Metastasis (M) describes whether the cancer has spread to a different part of the body.

M0 means that there is no sign that the cancer has spread. cMo(i+) means there is no sign of the cancer on physical examination, scans or x-rays. But cancer cells are present in blood, bone marrow, or lymph nodes far away from the breast cancer - the cells are found by laboratory tests M1 means the cancer has spread to another part of the body.

3 years
Clinicopathological characteristics of cancer: histopathological differentiation degree
Time Frame: 3 years

Cancer cells are given a Grade (G) when they are removed from the breast and checked under a microscope. The G is based on how much the cancer cells look like normal cells.

G1 or well differentiated (score 3, 4, or 5): cells are slower-growing, and look more like normal breast tissue.

G2 or moderately differentiated (score 6, 7): cells are growing at a speed of and look like cells somewhere between G1 and 3.

G3 or poorly differentiated (score 8, 9): cells look very different from normal and will probably grow and spread faster.

The histopathological differentiation is analyzed on tumor samples. The collection of a sample of the primary archival tumor and/or a sample of metastatic lesions will be requested, when available.

3 years
Clinicopathological characteristics of cancer: hormonal receptor status
Time Frame: 3 years

Receptors (R) are proteins in or on cells that can attach to certain substances in the blood. Normal breast cells and some breast cancer cells have R that attach to the hormones estrogen and progesterone, and depend on these hormones to grow.

Breast cancer cells may have one, both, or none of these R:

  • Estrogen Receptors (ER) -positive: are called ER-positive (or ER+) cancers.
  • Progesterone Receptors (PR) -positive: are called PR-positive (or PR+) cancers.
  • Hormone receptor (HR) -positive: If the cancer cell has one or both of the R above, the term hormone-receptive positive (also called hormone-positive or HR+) breast cancer may be used.
  • HR-negative: If the cancer cell has neither the ER nor the PR, it's called hormone-receptor negative (also called hormone-negative or HR-).

The hormonal R status is analyzed on tumor samples. The collection of a sample of the primary archival tumor and/or a sample of metastatic lesions will be requested, when available.

3 years
Clinicopathological characteristics of cancer: human epidermal growth factor receptor 2 (HER2) condition
Time Frame: 3 years

HER2 is a growth-promoting protein on the outside of all breast cells. Cells with higher than normal levels of HER2 are called HER2+. These cancers tend to grow and spread faster than other breast cancers, but are much more likely to respond to treatment with drugs that target the HER2 protein.

A biopsy or surgery sample of the cancer is tested with either immunohistochemical stains (IHC) or Fluorescent in situ hybridization (FISH).

  • IHC result 0 or 1+: cancer is considered HER2-negative. These cancers do not respond to treatment with drugs that target HER2.
  • IHC result is 3+: the cancer is HER2-positive. These cancers are usually treated with drugs that target HER2.
  • IHC result is 2+: HER2 status of the tumor is not clear and is called "equivocal." HER2 status needs to be tested with FISH to clarify the result.

HER2 is analyzed on tumor samples. The collection of a sample of the primary archival tumor and/or a sample of metastatic lesions will be requested, when available.

3 years
Clinicopathological characteristics of cancer: Ki67 proliferation index
Time Frame: 3 years

Ki-67 is a protein in cells that increases as they prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. The more positive cells there are, the more quickly they are dividing and forming new cells. In breast cancer, a result of less than 10% is considered low, 10-20% borderline, and high if more than 20%.

Ki-67 is analyzed on tumor samples. The collection of a sample of the primary archival tumor and/or a sample of metastatic lesions will be requested, when available.

3 years
Clinicopathological characteristics of cancer: BRCA1 and 2 mutations
Time Frame: 3 years

BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins. These proteins help repair damaged DNA and, therefore, play a role in ensuring the stability of each cell's genetic material. When either of these genes is mutated, or altered, such that its protein product is not made or does not function correctly, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.

People who have inherited mutations in BRCA1 and BRCA2 tend to develop breast and ovarian cancers at younger ages than people who do not have these mutations.

BRCA1 and 2 mutations are analyzed on whole blood samples, that are preferably collected at the enrolment visit (after signing the informed consent).

3 years
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.
Time Frame: 3 years
Disease-free survival (DFS): It is defined as the time from date of initial breast cancer surgery to the date of the first documented relapse event (local, regional and/or distant) of the disease, second breast or non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.
3 years
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.
Time Frame: 3 years
Event-free survival (EFS): It is defined as the time from date of breast cancer diagnosis to the date of the first documented event of disease progression which excludes the potentially curative surgery, relapse (local, regional and/or distant) of the disease after the curative surgery, second breast or non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.
3 years
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.
Time Frame: 3 years
Progression-free survival (PFS): It is defined as the time from the start date of a specific treatment to the documentation of disease progression on such treatment, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.
3 years
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.
Time Frame: 3 years
Overall survival (OS): It is defined as the time from date of initial breast cancer diagnosis to the date of death due to any cause.
3 years
Correlation of the molecular profiles identified with the patients' clinicopathological and epidemiological characteristics and their disease evolution.
Time Frame: 3 years
3 years
Association between gestational breast cancer and a specific genotype or gene expression profile.
Time Frame: 3 years
3 years
Number of patients with breast cancer managed to get pregnant, spontaneously or through in vitro fertilization (IVF) methods
Time Frame: 3 years
Number of patients with breast cancer managed to get pregnant, spontaneously or through in vitro fertilization (IVF) methods, considering both the patients with early disease and the patients with advanced disease.
3 years
Number of patients with breast cancer that have followed fertility preservation techniques and what type of techniques were used.
Time Frame: 3 years
3 years
Enumerate the potential risks of fertility preservation techniques in women with breast cancer.
Time Frame: 3 years
3 years
Pregnancy outcome from women diagnosed with gestational breast cancer or women with breast cancer diagnosis who became pregnant.
Time Frame: 3 years
3 years
Progress of the babies born from women diagnosed with gestational breast cancer or women with breast cancer diagnosis who became pregnant.
Time Frame: 3 years
Regarding the live-born children, serious diseases and age until the progression is known.
3 years

Other Outcome Measures

Outcome Measure
Time Frame
Potential relationship of clinical activity biomarkers and the probability of developing gestational breast cancer or having a relapse after the pregnancy
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Study Director, Instituto Valenciano de Oncología, Valencia, España
  • Study Director: Study Director, Hospital Universitario Reina Sofía de Córdoba, Córdoba, España
  • Study Director: Study Director, Hospital Clínico Universitario de Valencia, Valencia, España
  • Study Director: Study Director, Centro Nacional de Epidemiología. Instituto de Salud Carlos III, Madrid, España

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Estimated)

January 1, 2040

Study Completion (Estimated)

January 1, 2040

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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