Breast Cancer in Pregnancy Register Study

NCT ID: NCT00196833

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-04-30

Study Completion Date

2026-04-30

Brief Summary

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Women who were diagnosed with breast cancer during their pregnancy may be registered in this trial.

Data is collected on the foetal outcome 4 weeks after delivery, maternal outcome of pregnancy as well as the breast cancer therapy applied (treatment, response to chemotherapy, type of surgery), diagnostic procedures applied (palpation, US, mammogram) and the outcome of mother and child after 5 years of therapy.

Detailed Description

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Breast cancer is the most common cancer malignancy in women of childbearing age after the age of 25 years. Since the incidence of breast cancer under the age of 40 is increasing, and women tend to delay pregnancy into later reproductive years, the coincidence of pregnancy and breast cancer is increasing. About 1 in 1,000 pregnancies is complicated by breast cancer. Nevertheless, little is known about the right therapy for the mother and the unborn child. We are therefore carrying out a trial, collecting prospective and retrospective data about pregnant women, with histological confirmed breast cancer. Data on the biology of the tumour and placenta tissues is also collected. The anonymous data is collected in a database.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Cohort 1: Women with histologically confirmed breast cancer during pregnancy
* Cohort 2: Patients ≤ 40 years with histological confirmed breast cancer who are not pregnant (patients who have been pregnant recently can also be collected into this cohort)
* Informed consent for data collection (for prospective participants) and biomaterial collection. For retrospective participants an informed consent is not required as long as the data are anonymously captured

Exclusion Criteria

* Cohort 1: Diagnosis of breast cancer outside the period of pregnancy
* Cohort 2: Age at diagnosis of breast cancer \> 40 years
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Goethe University

OTHER

Sponsor Role collaborator

GBG Forschungs GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sibylle Loibl, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

GBG Forschungs GmbH

Locations

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German Breast Group

Neu-Isenburg, Hesse, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sibylle Loibl, Prof. Dr.

Role: CONTACT

+49 6102-7480- ext. 426

Facility Contacts

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Sibylle Loibl, Prof. Dr.

Role: primary

+49 6102 7840 ext. 426

References

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Loibl S, Han SN, von Minckwitz G, Bontenbal M, Ring A, Giermek J, Fehm T, Van Calsteren K, Linn SC, Schlehe B, Gziri MM, Westenend PJ, Muller V, Heyns L, Rack B, Van Calster B, Harbeck N, Lenhard M, Halaska MJ, Kaufmann M, Nekljudova V, Amant F. Treatment of breast cancer during pregnancy: an observational study. Lancet Oncol. 2012 Sep;13(9):887-96. doi: 10.1016/S1470-2045(12)70261-9. Epub 2012 Aug 16.

Reference Type DERIVED
PMID: 22902483 (View on PubMed)

Related Links

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http://www.germanbreastgroup.de

Click here for more information about this study: Breast Cancer in Pregnancy

Other Identifiers

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BIG 2-03

Identifier Type: OTHER

Identifier Source: secondary_id

GBG 29

Identifier Type: -

Identifier Source: org_study_id

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